ADC ID	DRG0CECRA
ADC Name	Trastuzumab rezetecan
Synonyms	trastuzumab rezetecan; SHR-A1811    Click to Show/Hide
Organization	Jiangsu Hengrui Pharmaceuticals (Originator);Glenmark Specialty
Drug Status	Approved in 2025
Drug-to-Antibody Ratio	5.3 to 6.4 (~6)
Structure
	3D MOL			2D MOL
Antibody Name	Trastuzumab					Antibody Info
Antigen Name	Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)					Antigen Info
Payload Name	SHR9265					Payload Info
Therapeutic Target	DNA topoisomerase 1 (TOP1)					Target Info
Linker Name	Mc-Gly-Gly-Phe-Gly					Linker Info
Conjugate Type	Random Cysteines
Combination Type	rezetecan
Special Approval(s)	Breakthrough therapy (NMPA); Special approval (NMPA)

Bystander Killing Effect	Description	Reference
yes	In the bystander killing system, SHR-A1811 was able to kill both SK-BR-3 (HER2+) and MDA-MB-468 (HER2-) cells when co-cultured, with the IC50 on MDA-MB-468 of 0.28 nM.	[3]

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (Cmax)	77	ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	412	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0688	day	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	106	ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	592	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	659	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	588	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0632	day	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	133	ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	746	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	845	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	728	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.104	day	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	164	ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	739	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	829	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	750	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0625	day	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	175	ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	975	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1170	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	995	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0625	day	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	70	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	524	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.124	day	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	120	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	873	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1040	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	887	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0347	day	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	132	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	969	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	981	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0354	day	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Maximum Observed Concentration (Cmax)	160	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	945	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-t.	[1]
Time to Maximum Concentration (Tmax)	0.0208	day	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Time to Maximum Concentration (Tmax)	0.0406	day	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose.	[2]
Maximum Observed Concentration (Cmax)	649048	ng/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose.	[2]
Area Under the Concentration-Time Curve (AUC)	3111089	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	3489237	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCinf.	[2]
Time to Maximum Concentration (Tmax)	0.0243	day	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose.	[2]
Maximum Observed Concentration (Cmax)	801109	ng/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose.	[2]
Area Under the Concentration-Time Curve (AUC)	3988273	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	4524900	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCinf.	[2]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	412	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.6	L	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	592	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	659	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	588	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	4	L	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	746	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	845	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	728	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.8	L	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	739	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	829	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	750	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	4.4	L	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	975	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1170	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	995	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.8	L	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	4.1	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	524	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.8	L	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	873	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1040	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	887	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.7	L	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	969	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	981	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	3.7	L	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	6.9	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	945	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-t.	[1]
Volume of Distribution (Vd)	2.5	L	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	3111089	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	3489237	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCinf.	[2]
Area Under the Concentration-Time Curve (AUC)	3988273	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	4524900	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCinf.	[2]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	412	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-t.	[1]
Area Under the Concentration-Time Curve (AUC)	592	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	659	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	588	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-t.	[1]
Area Under the Concentration-Time Curve (AUC)	746	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	845	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	728	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-t.	[1]
Area Under the Concentration-Time Curve (AUC)	739	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	829	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	750	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-t.	[1]
Area Under the Concentration-Time Curve (AUC)	975	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1170	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	995	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-t.	[1]
Minimum Observed Concentration (Cmin)	4.1	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	524	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-t.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	873	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1040	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	887	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-t.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	969	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	981	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-t.	[1]
Minimum Observed Concentration (Cmin)	6.9	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	945	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-t.	[1]
Area Under the Concentration-Time Curve (AUC)	3111089	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	3489237	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCinf.	[2]
Area Under the Concentration-Time Curve (AUC)	3988273	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	4524900	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCinf.	[2]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	412	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	391	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	5.1	day	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg.	[1]
Clearance (CL)	0.5	L/day	Pharmacokinetic parameters after single dosing (cycle 1), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	592	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	659	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	588	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	6.4	day	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg.	[1]
Clearance (CL)	0.5	L/day	Pharmacokinetic parameters after single dosing (cycle 1), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	746	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	845	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	728	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	6.9	day	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg.	[1]
Clearance (CL)	0.4	L/day	Pharmacokinetic parameters after single dosing (cycle 1), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	739	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	829	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	750	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	6.5	day	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg.	[1]
Clearance (CL)	0.6	L/day	Pharmacokinetic parameters after single dosing (cycle 1), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	975	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1170	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	995	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	7.5	day	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg.	[1]
Clearance (CL)	0.4	L/day	Pharmacokinetic parameters after single dosing (cycle 1), 8.0 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	4.1	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	524	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	472	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	6.7	day	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Clearance (CL)	0.4	L/day	Pharmacokinetic parameters after single dosing (cycle 3), 3.2 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	873	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1040	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	887	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	8.1	day	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Clearance (CL)	0.4	L/day	Pharmacokinetic parameters after single dosing (cycle 3), 4.8 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	10.2	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	969	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	981	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	8	day	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Clearance (CL)	0.3	L/day	Pharmacokinetic parameters after single dosing (cycle 3), 5.6 mg/kg.	[1]
Minimum Observed Concentration (Cmin)	6.9	ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-21d.	[1]
Area Under the Concentration-Time Curve (AUC)	945	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUCinf	[1]
Area Under the Concentration-Time Curve (AUC)	897	day*ug/mL	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg, AUC0-t.	[1]
Elimination Half-Life (t1/2)	4.8	day	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Clearance (CL)	0.4	L/day	Pharmacokinetic parameters after single dosing (cycle 3), 6.4 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	3111089	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	3489237	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose, AUCinf.	[2]
Elimination Half-Life (t1/2)	6.8	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after single dose.	[2]
Area Under the Concentration-Time Curve (AUC)	3988273	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCt.	[2]
Area Under the Concentration-Time Curve (AUC)	4524900	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose, AUCinf.	[2]
Elimination Half-Life (t1/2)	7.06	ng*day/mL	Toxicokinetics parameters of SHR-A1811 (40 mg/kg) in cynomolgus monkeys after multiple dose.	[2]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Objective Response Rate (ORR)	NCT04513223	PHASE1	Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study    Click to Show/Hide
Objective Response Rate (ORR)	NCT04818333	PHASE1|||PHASE2	Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation    Click to Show/Hide
Objective Response Rate (ORR)	NCT04446260	PHASE1	A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects    Click to Show/Hide
Objective Response Rate (ORR)	NCT05896020	PHASE2	Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
Objective Response Rate (ORR)	NCT05353361	PHASE2	A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer
Objective Response Rate (ORR)	NCT05911958	PHASE2	Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Objective Response Rate (ORR)	NCT05769010	PHASE2	A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases
Objective Response Rate (ORR)	NCT05924256	PHASE2	A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Objective Response Rate (ORR)	NCT05635487	PHASE2	A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Disease control rate (DCR)	NCT04513223	PHASE1	Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study    Click to Show/Hide
Disease control rate (DCR)	NCT04446260	PHASE1	A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects    Click to Show/Hide
Disease control rate (DCR)	NCT04818333	PHASE1|||PHASE2	Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation    Click to Show/Hide
Disease control rate (DCR)	NCT05924256	PHASE2	A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Undisclosed	NCT05582499	PHASE2	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
Undisclosed	NCT05424835	PHASE3	A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane    Click to Show/Hide
Undisclosed	NCT05792410	PHASE1|||PHASE2	An Open, Multicenter Phase Ib/II Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.    Click to Show/Hide
Undisclosed	NCT05814354	PHASE3	A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
Undisclosed	NCT05824325	PHASE1|||PHASE2	Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ib/II Study(GALAXY)
Undisclosed	NCT05845138	PHASE1|||PHASE2	An Open-Label, Multi-center Phase Ib/II Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Undisclosed	NCT06057610	PHASE3	A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer    Click to Show/Hide
Undisclosed	NCT06126640	PHASE3	A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy    Click to Show/Hide
Undisclosed	NCT06222879	PHASE1|||PHASE2	A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer    Click to Show/Hide
Undisclosed	NCT06340230	PHASE2	A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Undisclosed	NCT06361979	PHASE2	A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
Undisclosed	NCT06411457	PHASE2	Single-arm, Multi-center Phase II Clinical Study of SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
Undisclosed	NCT06433609	PHASE2	A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Undisclosed	NCT06592625	PHASE2	A Multicenter, Single-arm, Phase 2 Study of Neoadjuvant SHR-A1811 Plus Adebrelimab Injection for Early-stage or Locally Advanced HR Negative or Low Expression/HER2 Low Expression Breast Cancer
Undisclosed	NCT06649331	PHASE2	Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer:A Prospective, Open-label, Multicenter, Phase II Trial
Undisclosed	NCT06710990	PHASE1	A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer    Click to Show/Hide
Undisclosed	NCT06718933	PHASE1|||PHASE2	A Prospective, Single-arm, Exploratory, Phase Ib/II Study of SHR-A1811 Combined with Pyrotinib and Bevacizumab in Advanced Breast Cancer with Brain Metastasis.
Undisclosed	NCT06788197	PHASE1|||PHASE2	A Phase Ib/II Study of SHR-A1811 and Fulvestrant in Combination With or Without HS-10352 in Locally Advanced or Metastatic Breast Cancer Patients Who Progressed After Adjuvant Therapy
Undisclosed	NCT06547736	PHASE2	A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer
Undisclosed	NCT05594095	PHASE2	Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
Undisclosed	NCT06859775	PHASE1|||PHASE2	Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Undisclosed	NCT06413745	PHASE2	A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy    Click to Show/Hide
Undisclosed	NCT06778031	PHASE2	An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Undisclosed	NCT06199973	PHASE3	Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
Undisclosed	NCT06666166	PHASE2	Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Undisclosed	NCT05671822	PHASE2	A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Undisclosed	NCT05482568	PHASE1|||PHASE2	Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2    Click to Show/Hide
Undisclosed	NCT06430437	PHASE3	A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
Undisclosed	NCT06828354	PHASE3	An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer    Click to Show/Hide
Undisclosed	NCT06840002	PHASE1|||PHASE2	An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
Undisclosed	NCT05349409	PHASE2	A Phase Ib/II Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Undisclosed	NCT06015048	PHASE1|||PHASE2	A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
Objective Response Rate (ORR)	NCT04446260	Phase 1	A phase 1 multi-country, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A1811 in HER2 expressing or mutated advanced malignant solid tumor subjects.    Click to Show/Hide
Undisclosed	NCT05424835	Phase 3	A phase 3, multicenter, randomized, open-label, parallel controlled study of SHR-A1811 versus pyrotinib in combination with capecitabine for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.    Click to Show/Hide
Undisclosed	NCT05594095	Phase 2	Precision platform study of HR+/ HER2-advanced breast cancer based on snf typing (a prospective, open-label, multi-center, phase 2 platform study).
Undisclosed	NCT05749588	Phase 2	Precision platform study of refractory triple-negative breast cancer based on molecular subtyping (a phase 2, open-label, single-center platform study).
Undisclosed	NCT05769010	Phase 2	A prospective, open-label explorative study of SHR-A1811 in HER2-expression advanced breast cancer with brain metastases.
Undisclosed	NCT05353361	Phase 2	A phase 1b/2 multicenter, open-label clinical trial of SHR-A1811 injection in combination with pyrotinib or pertuzumab or SHR-1316 or paclitaxel for injection (albumin bound) in HER2-positive breast cancer.    Click to Show/Hide
Undisclosed	NCT05671822	Phase 2	A phase 1b/2 study of SHR-A1811 combinations in patients with advanced/metastatic HER2+ gastric /gastroesophageal junction adenocarcinoma.
Undisclosed	NCT05635487	Phase 2	A single-arm, phase 2 study of SHR-A1811 combined with pyrotinib maleate as neoadjuvant treatment in HER2-positive breast cancer patients.
Undisclosed	NCT05349409	Phase 2	A phase 1b/2 clinical study on the dosage exploration and efficiency expansion of SHR-A1811 for injection in combination with fluzoparib capsule in HER2-expressing advanced solid tumors of patients.
Undisclosed	NCT05582499	Phase 1/2	Fudan university shanghai cancer center breast cancer precision platform series study- neoadjuvant therapy (FASCINATE-N).
Undisclosed	NCT05482568	Phase 1/2	Phase 1B/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of injectable SHR-A1811 in combination with pyrotinib or SHR-1316 in subjects with advanced non-small cell lung cancer with HER2.    Click to Show/Hide
Undisclosed	NCT04818333	Phase 1/2	Phase 1/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression, amplification, or mutation.    Click to Show/Hide
Undisclosed	NCT04513223	Phase 1	Safety, tolerability, pharmacokinetics, and antitumour activity of SHR-A1811, in patients with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer: a phase 1 study.    Click to Show/Hide

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximal inhibitory Concentration (lC50)	0.42 ± 0.10	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	0.57 ± 0.15	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	0.77 ± 0.10	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	11.3 ± 2.7	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	42.5 ± 7.8	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	59.1 ± 17.2	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	97.3 ± 23.1	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	132.6	nM	CVCL_0434	Gastric adenocarcinoma
Half Maximal inhibitory Concentration (lC50)	302.9 ± 87	nM	CVCL_0434	Gastric adenocarcinoma

Experiment 1 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Objective Response Rate (ORR)	38.20%
Patients Enrolled	Eligible patients must have advanced/metastatic gastric/GEJ adenocarcinoma or colorectal cancer (refractory to standard therapy) with ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, life expectancy ≥3 months, and adequate organ function. Exclusions: unresolved Grade >1 toxicities, prior HER2-ADC exposure, symptomatic CNS/meningeal metastases, or active infections requiring systemic treatment.    Click to Show/Hide
Administration Dosage	There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Related Clinical Trial
NCT Number	NCT04513223	Clinical Status	PHASE1
Clinical Description	Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
Primary Endpoint	The primary endpoints include assessment of dose-limiting toxicities (DLT) and determination of the recommended Phase 2 dose (RP2D) during the first treatment cycle (Days 1-21).
Experiment 2 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Objective Response Rate (ORR)	41.90%
Patients Enrolled	Eligible patients (ECOG 0-1, HER2-altered advanced NSCLC post-platinum failure) require ≥1 measurable lesion (RECIST v1.1). Key exclusions: unresolved Grade >1 toxicity (CTCAE v5.0), prior HER2 ADC treatment, symptomatic CNS/meningeal metastases, or active systemic infection.
Administration Dosage	SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
Related Clinical Trial
NCT Number	NCT04818333	Clinical Status	PHASE1|||PHASE2
Clinical Description	Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation
Primary Endpoint	Phase 1 evaluates safety/tolerability of SHR-A1811 through incidence/severity of AEs (CTCAE v5.0; monitored Day1-90 post-last dose, ~3 years), MTD determination (DLTs in first 21-day cycle), and RP2D selection (based on safety/PK/efficacy over 12 months). Phase 2 primary endpoint is ORR (RECIST v1.1, IRC-assessed, tumor imaging q6w→q12w post-54w until progression/new therapy/death, ~3 years).    Click to Show/Hide
Other Endpoint	Phase 1 PK analysis includes Tmax, Cmax, AUC0-t (~3 years); immunogenicity (ADA/NAb assessed pre-dose C1D1-C8D1→q3 cycles). Phase 2 secondary endpoints: IRC/investigator-assessed PFS, ORR, DOR, DCR (RECIST v1.1, ~3 years); OS (~5 years post-last enrollment).
Experiment 3 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Objective Response Rate (ORR)	45.90%
Patients Enrolled	Eligible patients must have HER2-positive advanced/metastatic solid tumors refractory to standard therapy, ECOG 0-1, LVEF ≥ 50%, and adequate organ function. Exclusions include significant lung disease, bleeding/thrombotic disorders, and pregnancy or lactation during the study.
Administration Dosage	Patients (pts) with advanced, unresectable, or metastatic HER2-expressing/mutated STs that were refractory or intolerant to standard therapies were treated with SHR-A1811 at 1.0-8.0 mg/kg Q3W (IV).
Related Clinical Trial
NCT Number	NCT04446260	Clinical Status	PHASE1
Clinical Description	A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
Primary Endpoint	The study monitors the incidence and severity of adverse events (AEs) from Day 1 to 90 days after the last dose, including frequency and seriousness of treatment-emergent adverse events (TEAEs).
Other Endpoint	Pharmacokinetic (PK) parameters such as Tmax, Cmax, and AUC0-t of SHR-A1811 are evaluated over an average of 1 year. Immunogenicity assessments include anti-drug antibodies and neutralizing antibodies. Tumor response is measured per RECIST 1.1 until progression or death, up to 30 months.
Experiment 4 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Objective Response Rate (ORR)	56.1 50 63.6 %
Patients Enrolled	Eligible participants (signed ICF, ECOG 0-1, life expectancy ≥12 weeks) must have measurable advanced/recurrent cervical, ovarian, or endometrial cancer. Exclusions: untreated CNS metastases, prior topoisomerase I inhibitor ADC treatment (e.g., DS-8201a), uncontrolled cardiovascular disease, active autoimmune/HBV/HCV infections, recent severe infections (28 days), or active tuberculosis (1 year).    Click to Show/Hide
Administration Dosage	Pts received SHR-A1811 at 4.8 or 6.4 mg/kg (Q3W, IV). The primary endpoint was ORR per RECIST v1.1.
Related Clinical Trial
NCT Number	NCT05896020	Clinical Status	PHASE2
Clinical Description	Open, Multicenter Phase II Clinical Study of SHR-A1811 for Injection in the Treatment of Gynaecological Malignancies
Primary Endpoint	The primary endpoint is objective response rate (ORR) assessed over a 12-month timeframe as per RECIST v1.1 criteria.
Other Endpoint	Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS) (all 12-month assessment), and incidence/severity of adverse events (AEs) tracked from Day 1 to 90 days post-last dose.
Experiment 5 Reporting the Activity Date of This ADC					[7]
Efficacy Data	Objective Response Rate (ORR)	66.70%
Patients Enrolled	Eligible patients (women 18-75 years, ECOG 0-1) require histologically confirmed HER2+ breast cancer, measurable lesions (RECIST v1.1), and adequate organ function. Key exclusions: active CNS metastases (unless treated), uncontrolled effusions, recent antitumor therapy (≤4 weeks), autoimmune/cardiovascular diseases, or unresolved toxicity (>CTCAE Gr1). Hepatitis B/C carriers with viral loads >2000 IU/mL or cirrhosis are excluded.    Click to Show/Hide
Administration Dosage	SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip
Related Clinical Trial
NCT Number	NCT05353361	Clinical Status	PHASE2
Clinical Description	A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer
Primary Endpoint	The Phase I dose-escalation trial evaluates SHR-A1811 safety (DLTs in first 21 days; AEs/SAEs monitored until 40-90 days post-treatment). Phase II assesses ORR (primary endpoint) in HER2+ breast cancer patients at 2 years post-enrollment, with tumor response per RECIST v1.1.
Other Endpoint	Pharmacokinetics (Cmin/Cmax/AUC of SHR-A1811, pyrotinib, and adebrelimab) and immunogenicity (anti-drug antibodies) are secondary endpoints in both phases (tracked for ~2 years). Efficacy metrics include ORR, DoR, PFS (up to 3 years), and Phase II's event-free survival rate (EFSR). Safety monitoring extends to 90 days post-treatment.
Experiment 6 Reporting the Activity Date of This ADC					[8]
Efficacy Data	Objective Response Rate (ORR)	81.50%
Patients Enrolled	Eligible patients aged 18-70 have untreated T2-T3/N0-3/M0, HR+/HER2-low (Ki-67 >14%) invasive breast cancer (ECOG 0-1) and normal organ function. Exclusions: metastatic/inflammatory disease, prior anticancer therapy (excluding cured non-breast malignancies), recent major surgery, severe comorbidities (cardiopulmonary/immunodeficiency), drug allergies, or conditions impairing treatment adherence. WOCBP must use contraception.    Click to Show/Hide
Administration Dosage	SHR-A1811 is administered intravenously at a dose of 6.4 mg/kg once every three weeks for a total of eight cycles.
Related Clinical Trial
NCT Number	NCT05911958	Clinical Status	PHASE2
Clinical Description	Phase II Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Primary Endpoint	The study evaluates ORR per RECIST v1.1 during 24 weeks of neoadjuvant treatment and assesses safety via AE incidence/severity (CTCAE 5.0) from consent through 28 days post-last dose.
Other Endpoint	Key endpoints include residual cancer burden (RCB) and pathological complete response (pCR: ypT0/is ypN0) at surgery, with long-term outcomes tracked over 5 years (EFS from randomization; DFS from surgery) for recurrence/metastasis/death events.
Experiment 7 Reporting the Activity Date of This ADC					[9]
Efficacy Data	Objective Response Rate (ORR)	84.4 72.7 %
Patients Enrolled	Eligible participants are females ≥18 with HER2+/HER2-low advanced breast cancer and measurable untreated intracranial lesions (RANO-BM). Key criteria: no prior cranial radiation/local therapy (unless post-surgery, unirradiated), ≥2 weeks since last systemic treatment, life expectancy ≥6 months, and adequate organ function. Exclusions: leptomeningeal disease, urgent CNS intervention needed, prior DS-8201a/exatecan-ADC use, recent antitumor therapy (≤2 weeks for most, ≤1 week for endocrine), other malignancies (except cured CIS/skin cancers), or uncontrolled comorbidities per investigator judgement.    Click to Show/Hide
Administration Dosage	Between March 31, 2023, and November 3, 2023, 25 patients with HER2+ BCBM were enrolled in Arm 1, and they received SHR-A1811 at a dosage of 6.4mg/kg q3w.
Related Clinical Trial
NCT Number	NCT05769010	Clinical Status	PHASE2
Clinical Description	A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases
Primary Endpoint	The primary endpoint is CNS-ORR, assessed by investigators per RANO-BM criteria at 2 months, defined as the percentage of participants achieving CNS response.
Other Endpoint	Secondary endpoints include ORR (CR/PR per RECIST 1.1 at 2 months), PFS (time to progression/death up to 1.5 years), and safety (adverse events incidence over 1.5 years).
Experiment 8 Reporting the Activity Date of This ADC					[10]
Efficacy Data	Objective Response Rate (ORR)	85.7 30 %
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1, life expectancy &ge;12 weeks) must have histologically confirmed locally advanced/metastatic salivary gland carcinoma: Arm 1 (HER2-altered), Arm 2 (AR-positive), Arm 3 (HER2/AR-negative), or Arm 4 (low HER2 expression), with &ge;1 measurable lesion (RECIST v1.1). Key exclusions: active malignancies (5 years), recent antitumor therapy (28 days prior, or <5 half-lives), uncontrolled cardiac conditions (NYHA &ge;II, LVEF <50%, QTc >450ms&male;/470ms&female;), uncontrolled hypertension, gastrointestinal absorption issues (Arm 2), bleeding risks, or abnormal coagulation (INR/aPTT >1.5&times;ULN). Organ function thresholds: HB &ge;90g/L, ANC &ge;1.5&times;10<sup>9</sup>/L, PLT &ge;80&times;10<sup>9</sup>/L, bilirubin &le;1.5&times;ULN, ALT/AST &le;2.5&times;ULN (&le;5&times;ULN if liver mets), Cr &le;1&times;ULN.    Click to Show/Hide
Administration Dosage	Patients with advanced SGC were stratified into four arms based on genetic subtypes. This analysis focuses on Arm 1 (HER2 overexpression: IHC 3+ or IHC 2+/ISH+) and Arm 4 (HER2-low: IHC 1+ or IHC 2+/ISH-). In Arm 1, patients received SHR-A1811 at 4.8 mg/kg IV on Day 1 of a 21-day cycle. In Arm 4, patients received 4.8 mg/kg or 5.6 mg/kg (if tolerated).    Click to Show/Hide
Related Clinical Trial
NCT Number	NCT05924256	Clinical Status	PHASE2
Clinical Description	A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Primary Endpoint	The primary endpoint is objective response rate (ORR) assessed every 2 cycles (21-day cycles for Arms 1/3/4, 28-day for Arm 2) per RECIST 1.0 criteria (confirmed CR/PR).
Other Endpoint	Key secondary endpoints include disease control rate (DCR: CR/PR/SD per RECIST 1.0, same assessment schedule), progression-free survival (PFS: time to progression/death, RECIST v1.1, up to 2 years), overall survival (OS: time to death, up to 2 years), and adverse events (hematologic/non-hematologic per CTCAE 5.0, monitored from consent to 30 days post-last cycle).    Click to Show/Hide
Experiment 9 Reporting the Activity Date of This ADC					[11]
Efficacy Data	Objective Response Rate (ORR)	89.70%
Patients Enrolled	Eligible patients (females aged 18-75) have treatment-naive HER2+ stage II-III breast cancer (ECOG 0-1). Exclusions: prior antitumor therapy, bilateral/Stage IV disease, malignancies in 5 years (exceptions: cured CIS/skin cancer), drug absorption issues, recent trial participation, significant organ dysfunction (cardiac/pulmonary/liver), or drug allergies.    Click to Show/Hide
Administration Dosage	Eligible women aged 18-75 with newly diagnosed stage II-III, untreated HER2+ BC received SHR-A1811 Q3W and daily pyrotinib for six cycles. Initial treatment was SHR-A1811 at 4.8 mg/kg and pyrotinib at 240 mg/day (Cohort A). Dose adjustments followed the 3+3 principle: If tolerated, SHR-A1811 could escalate to 5.6 mg/kg, maintaining pyrotinib (Cohort B). For intolerance or investigator discretion, adjustments included SHR-A1811 at 4.8 mg/kg with pyrotinib at 160 mg/day (Cohort C), or SHR-A1811 at 4.0 mg/kg with pyrotinib at 240 mg/day (Cohort D).    Click to Show/Hide
Related Clinical Trial
NCT Number	NCT05635487	Clinical Status	PHASE2
Clinical Description	A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Primary Endpoint	The primary endpoint is total pathological complete response (tpCR: ypT0-is/ypN0), evaluated at surgery following neoadjuvant therapy.
Other Endpoint	Secondary endpoints include breast pCR (bpCR: ypT0-is), RCB, BORR during neoadjuvant treatment (18 weeks), OS/DFS/EFS (5-year follow-up), and HRQOL (assessed via EORTC QLQ-C30 and QLQ-BR23).
Experiment 10 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Disease control rate (DCR)	83.60%
Patients Enrolled	Eligible patients must have advanced/metastatic gastric/GEJ adenocarcinoma or colorectal cancer (refractory to standard therapy) with &ge;1 measurable lesion (RECIST 1.1), ECOG 0-1, life expectancy &ge;3 months, and adequate organ function. Exclusions: unresolved Grade >1 toxicities, prior HER2-ADC exposure, symptomatic CNS/meningeal metastases, or active infections requiring systemic treatment.    Click to Show/Hide
Administration Dosage	There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Related Clinical Trial
NCT Number	NCT04513223	Clinical Status	PHASE1
Clinical Description	Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
Primary Endpoint	The primary endpoints include assessment of dose-limiting toxicities (DLT) and determination of the recommended Phase 2 dose (RP2D) during the first treatment cycle (Days 1-21).
Experiment 11 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Disease control rate (DCR)	88.20%
Patients Enrolled	Eligible patients must have HER2-positive advanced/metastatic solid tumors refractory to standard therapy, ECOG 0-1, LVEF &ge; 50%, and adequate organ function. Exclusions include significant lung disease, bleeding/thrombotic disorders, and pregnancy or lactation during the study.
Administration Dosage	Patients (pts) with advanced, unresectable, or metastatic HER2-expressing/mutated STs that were refractory or intolerant to standard therapies were treated with SHR-A1811 at 1.0-8.0 mg/kg Q3W (IV).
Related Clinical Trial
NCT Number	NCT04446260	Clinical Status	PHASE1
Clinical Description	A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
Primary Endpoint	The study monitors the incidence and severity of adverse events (AEs) from Day 1 to 90 days after the last dose, including frequency and seriousness of treatment-emergent adverse events (TEAEs).
Other Endpoint	Pharmacokinetic (PK) parameters such as Tmax, Cmax, and AUC0-t of SHR-A1811 are evaluated over an average of 1 year. Immunogenicity assessments include anti-drug antibodies and neutralizing antibodies. Tumor response is measured per RECIST 1.1 until progression or death, up to 30 months.
Experiment 12 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Disease control rate (DCR)	95.30%
Patients Enrolled	Eligible patients (ECOG 0-1, HER2-altered advanced NSCLC post-platinum failure) require &ge;1 measurable lesion (RECIST v1.1). Key exclusions: unresolved Grade >1 toxicity (CTCAE v5.0), prior HER2 ADC treatment, symptomatic CNS/meningeal metastases, or active systemic infection.
Administration Dosage	SHR-A1811 was administered intravenously every 3 weeks (Q3W) until discontinuation treatment
Related Clinical Trial
NCT Number	NCT04818333	Clinical Status	PHASE1|||PHASE2
Clinical Description	Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation
Primary Endpoint	Phase 1 evaluates safety/tolerability of SHR-A1811 through incidence/severity of AEs (CTCAE v5.0; monitored Day1-90 post-last dose, ~3 years), MTD determination (DLTs in first 21-day cycle), and RP2D selection (based on safety/PK/efficacy over 12 months). Phase 2 primary endpoint is ORR (RECIST v1.1, IRC-assessed, tumor imaging q6w→q12w post-54w until progression/new therapy/death, ~3 years).    Click to Show/Hide
Other Endpoint	Phase 1 PK analysis includes Tmax, Cmax, AUC0-t (~3 years); immunogenicity (ADA/NAb assessed pre-dose C1D1-C8D1→q3 cycles). Phase 2 secondary endpoints: IRC/investigator-assessed PFS, ORR, DOR, DCR (RECIST v1.1, ~3 years); OS (~5 years post-last enrollment).
Experiment 13 Reporting the Activity Date of This ADC					[10]
Efficacy Data	Disease control rate (DCR)	100%
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1, life expectancy &ge;12 weeks) must have histologically confirmed locally advanced/metastatic salivary gland carcinoma: Arm 1 (HER2-altered), Arm 2 (AR-positive), Arm 3 (HER2/AR-negative), or Arm 4 (low HER2 expression), with &ge;1 measurable lesion (RECIST v1.1). Key exclusions: active malignancies (5 years), recent antitumor therapy (28 days prior, or <5 half-lives), uncontrolled cardiac conditions (NYHA &ge;II, LVEF <50%, QTc >450ms&male;/470ms&female;), uncontrolled hypertension, gastrointestinal absorption issues (Arm 2), bleeding risks, or abnormal coagulation (INR/aPTT >1.5&times;ULN). Organ function thresholds: HB &ge;90g/L, ANC &ge;1.5&times;10<sup>9</sup>/L, PLT &ge;80&times;10<sup>9</sup>/L, bilirubin &le;1.5&times;ULN, ALT/AST &le;2.5&times;ULN (&le;5&times;ULN if liver mets), Cr &le;1&times;ULN.    Click to Show/Hide
Administration Dosage	Patients with advanced SGC were stratified into four arms based on genetic subtypes. This analysis focuses on Arm 1 (HER2 overexpression: IHC 3+ or IHC 2+/ISH+) and Arm 4 (HER2-low: IHC 1+ or IHC 2+/ISH-). In Arm 1, patients received SHR-A1811 at 4.8 mg/kg IV on Day 1 of a 21-day cycle. In Arm 4, patients received 4.8 mg/kg or 5.6 mg/kg (if tolerated).    Click to Show/Hide
Related Clinical Trial
NCT Number	NCT05924256	Clinical Status	PHASE2
Clinical Description	A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Primary Endpoint	The primary endpoint is objective response rate (ORR) assessed every 2 cycles (21-day cycles for Arms 1/3/4, 28-day for Arm 2) per RECIST 1.0 criteria (confirmed CR/PR).
Other Endpoint	Key secondary endpoints include disease control rate (DCR: CR/PR/SD per RECIST 1.0, same assessment schedule), progression-free survival (PFS: time to progression/death, RECIST v1.1, up to 2 years), overall survival (OS: time to death, up to 2 years), and adverse events (hematologic/non-hematologic per CTCAE 5.0, monitored from consent to 30 days post-last cycle).    Click to Show/Hide
Experiment 14 Reporting the Activity Date of This ADC					[12]
Patients Enrolled	Exclusion criteria include prior chemotherapy/radiotherapy, NYHA class II+ heart disease, severe infections, drug allergies, other malignancies (except cervical/non-melanoma skin cancer) in the past 5 years, pregnancy/lactation without contraception, participation in other trials within 30 days, or investigator-deemed unsuitability.
Administration Dosage	SHR-A1811 was administered at a dose of 4.8 mg/kg intravenously (i.v.) every 3 weeks for eight cycles with or without an irreversible dual pan-ErbB receptor TKI, pyrotinib 240 mg orally once daily.
Related Clinical Trial
NCT Number	NCT05582499	Clinical Status	PHASE2
Clinical Description	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)
Primary Endpoint	This study evaluates the pathological complete response rate (pCR) as the primary endpoint within 24 weeks, while secondary endpoints include three-year invasive disease-free survival (iDFS), overall response rate (ORR), adverse effects using CTCAE v4.0, gene expression profiling via RNA-seq, and peripheral blood mononuclear cell (PBMC) counts measured by flow cytometry throughout the treatment period.    Click to Show/Hide
Other Endpoint	Eligible participants must have histologically confirmed stage II-III invasive breast cancer (T2N0-1/T3N0 for stage II; T2N2/T3N1-2 for stage III), aged 18-70, ECOG 0-1, with confirmed ER/PR/HER2 status, LVEF ≥55%, and proper subtyping (SNF or triple-negative based on AR/CD8/FOXC1). Acceptable organ function is required (HB≥90g/L, ANC≥1500/uL, platelets≥75K/uL, bilirubin≤1.5xULN, AST/ALT≤3xULN, creatinine clearance>50mL/min). Fertile women must use contraceptives during and 3 months post-study.    Click to Show/Hide
Experiment 15 Reporting the Activity Date of This ADC					[13]
Patients Enrolled	Eligible patients must have unresectable/metastatic HER2+ breast cancer (prior trastuzumab + taxane treatment), ECOG 0-1, measurable disease (RECIST v1.1), and adequate organ function. Exclusions: uncontrolled effusions, recent antitumor therapy (&le;4 weeks for chemo/immunotherapy, &le;2 weeks for endocrine), active autoimmune/cardiac disease (NYHA &ge;II), HIV/HBV/HCV infection, unresolved toxicity (>CTCAE Gr1), or severe allergies to monoclonal antibodies. WOCBP must use contraception for 7 months post-treatment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05424835	Clinical Status	PHASE3
Clinical Description	A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Primary Endpoint	The primary endpoint is PFS (assessed by BIRC) evaluated from 6 weeks post-first dose until disease progression or death (approximately 2 years) in HER2+ metastatic breast cancer patients.
Experiment 16 Reporting the Activity Date of This ADC					[14]
Patients Enrolled	Inclusion requires HER2-low BC patients (18-75y, ECOG 0-1) with measurable lesions and adequate organ function. Key exclusions: active CNS metastases, uncontrolled effusions, recent major surgery, ILD/pneumonitis, significant comorbidities, unresolved prior toxicity (>CTCAE Gr1), or recent malignancies (exceptions: skin/CIS/thyroid cancers).
Administration Dosage	SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip
Related Clinical Trial
NCT Number	NCT05792410	Clinical Status	PHASE1|||PHASE2
Clinical Description	An Open, Multicenter Phase Ib/II Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
Primary Endpoint	The primary endpoints for Phase I include DLT assessment (cycle 1: 28d for SHR-A1811+fulvestrant, 21d for other combos), AE incidence/severity, and ORR evaluation during efficacy expansion, with follow-up up to 24 months.
Other Endpoint	Secondary measures comprise SHR-A1811/dalpiciclib PK profiles, ADA/NAb detection rates, DoR, and PFS, all monitored over 24 months. Safety and immunogenicity data span from treatment initiation through study completion.
Experiment 17 Reporting the Activity Date of This ADC					[15]
Patients Enrolled	Eligible patients have HR+/HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer with 0-1 prior chemotherapy lines in the metastatic setting, measurable lesions, and adequate organ function. Key exclusions: active CNS metastases (unless stable treated), HIV/autoimmune disease, ILD/pneumonitis history, significant CVD, active HBV/HCV infection, or prior malignancies (except low-risk) within 5 years.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05814354	Clinical Status	PHASE3
Clinical Description	A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
Primary Endpoint	The primary endpoint is PFS assessed by BIRC within approximately 2 years of follow-up.
Other Endpoint	Secondary endpoints include OS (time to death up to 3 years), ORR (CR/PR rate within ~2 years), DoR (response duration until progression/death), and CBR (CR/PR/SD rate per RECIST 1.1 over ~2 years).
Experiment 18 Reporting the Activity Date of This ADC					[16]
Patients Enrolled	Eligible patients have ECOG 0-1, HER2 IHC 0 advanced/metastatic breast cancer (never HER2+), measurable lesions (RECIST 1.1), and progression after &ge;1 chemotherapy line (HR+ tumors require prior endocrine therapy). Exclusions: prior anti-HER2 therapy, recent treatments (surgery/RT/systemic therapies within 4w; endocrine therapy within 2w), active CNS metastasis, immunosuppression (>10mg/day prednisone), uncontrolled comorbidities, HIV/HBV/HCV infection, or other malignancies (except cured skin/CIS) within 5 years.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05824325	Clinical Status	PHASE1|||PHASE2
Clinical Description	Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ib/II Study(GALAXY)
Primary Endpoint	Phase 1 focuses on AE incidence (graded per CTCAE v5.0) over 24 months, while Phase 2 evaluates ORR (CR/PR rate per RECIST 1.1 by investigator) until progression (~24 months).
Other Endpoint	Secondary endpoints include investigator-assessed PFS/OS (time to progression/death), DoR/DCR (response duration and control rate), CBR (CR/PR/SD≥24w), safety (AEs graded per CTCAE v5.0), and exploratory HER2-PET analysis, all monitored over 24 months.
Experiment 19 Reporting the Activity Date of This ADC					[17]
Patients Enrolled	Eligible are women aged 18-75 with HER2-low metastatic breast cancer (ECOG 0-1), measurable lesions, and &ge;12-week life expectancy. Exclusions: recent treatments/procedures (within 4 weeks), other cancers (last 5 years), significant comorbidities (cardiac/hepatic diseases), drug allergies, or conditions affecting absorption. WOCBP must use contraception.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05845138	Clinical Status	PHASE1|||PHASE2
Clinical Description	An Open-Label, Multi-center Phase Ib/II Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Primary Endpoint	The Phase I dose exploration focuses on DLT assessment within 21 days of first dose and tracks AE/SAE incidence from Day 1 to 40 days post-last dose, while Phase II evaluates ORR one year post-final enrollment.
Other Endpoint	Efficacy measures include DoR and PFS (assessed one year post-final enrollment), with Phase I also monitoring ORR during this period. Both phases document AE/SAE incidence from Day 1 to 40 days after the last treatment administration.
Experiment 20 Reporting the Activity Date of This ADC					[18]
Patients Enrolled	Eligible female patients (18-75 years) have HER2+ (IHC3+/ISH+) unresectable/metastatic breast cancer (ECOG 0-1, &ge;12-week life expectancy, measurable lesions per RECIST v1.1, adequate organ function). Exclusions: recent malignancies (past 5 years), untreated CNS metastases, early recurrence (<12 months post- (neo)adjuvant therapy), uncontrolled effusions, recent anti-tumor treatments (4 weeks prior), immunodeficiency, severe cardiovascular/interstitial lung disease, unresolved toxicity (>Grade 1), bleeding disorders, active hepatitis/cirrhosis, or other clinically significant comorbidities.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06057610	Clinical Status	PHASE3
Clinical Description	A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Primary Endpoint	The primary efficacy endpoint is blinded independent central review-assessed PFS, measured from first dose until disease progression or death (up to 3 years).
Other Endpoint	Secondary endpoints include investigator-assessed PFS (3 years), OS (6 years), ORR and DoR (3 years), plus AE/SAE incidence/severity tracked from Day 1 until 40-90 days post-last dose.
Experiment 21 Reporting the Activity Date of This ADC					[19]
Patients Enrolled	Eligible participants are women (18-75 years) with HER2+ invasive breast cancer (pre-neoadjuvant stage T1-4/N0-3/M0, excluding T1N0) and residual disease post-surgery/neoadjuvant therapy (&ge;9 weeks taxane + trastuzumab). Exclusions: metastatic/recurrent disease, prior HER2-ADC exposure, high anthracycline doses (>240mg/m2 doxorubicin or >480mg/m2 epirubicin), significant cardiovascular/respiratory disorders, hepatitis/liver cirrhosis, or conditions increasing study risk. HR status and ECOG 0-1 are required.    Click to Show/Hide
Administration Dosage	Lyophilized powder injection, 100mg / bottle, intravenous drip
Related Clinical Trial
NCT Number	NCT06126640	Clinical Status	PHASE3
Clinical Description	A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Primary Endpoint	The primary endpoint is invasive disease-free survival (IDFS), assessed from randomization until disease progression or approximately 77 months post-dose, evaluating long-term recurrence risk in HER2+ breast cancer patients.
Other Endpoint	Secondary endpoints include DFS, OS, and distant recurrence-free interval (DRFI), all tracked over extended periods (77-101 months post-dose), with safety assessed via AE incidence during the same timeframe, ensuring comprehensive monitoring of treatment efficacy and tolerability.
Experiment 22 Reporting the Activity Date of This ADC					[20]
Patients Enrolled	Eligible females (18-75 years, ECOG 0-1) have confirmed metastatic/locally advanced breast cancer (ER+/HER2&plusmn; or TNBC) with measurable lesions (RECIST v1.1) and organ function. Exclusions: uncontrolled brain metastases, active lung/cardiovascular diseases, recent immunosuppression, unresolved treatment toxicity (>Grade 1), active infections/hepatitis, prior malignancies (5 years), autoimmune/immunodeficiency disorders, or severe allergies to study drugs.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06222879	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Multi-center, Open-label Phase Ib/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Primary Endpoint	The Phase 1 study evaluates dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) within the first 21-day cycle, with safety monitored via AE/SAE incidence (CTCAE v5.0) and efficacy assessed by ORR over 12 months.
Other Endpoint	Immunogenicity (ADA/Nab levels for SHR-A1811, SHR-A2009, and adebrelimab) and efficacy (ORR, BOR, DoR, DCR, CBR, PFS) are tracked over 12 months in both Phase 1 and 2, alongside safety (AE/SAE incidence) to ensure comprehensive therapeutic assessment.
Experiment 23 Reporting the Activity Date of This ADC					[21]
Patients Enrolled	Eligible patients are treatment-naive women aged 18-75 with HR+/HER2-low stage II-III breast cancer, ECOG 0-1, and adequate organ function. Exclusions include prior anti-tumor therapy, stage IV disease, concurrent malignancies, significant comorbidities (cardiovascular, lung, liver, or psychiatric disorders), and participation in other trials within 4 weeks.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06340230	Clinical Status	PHASE2
Clinical Description	A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Primary Endpoint	The primary endpoint is total pathological complete response (tpCR: ypT0-is/ypN0) assessed at the time of surgery, measuring the absence of invasive cancer in the breast and lymph nodes.
Other Endpoint	Secondary endpoints include breast pathological complete response (bpCR: ypT0-is), residual cancer burden (RCB), best overall response rate (BORR) during neoadjuvant treatment, and long-term survival outcomes (OS, DFS, EFS) over 5 years. Health-related quality of life (HRQOL) is evaluated using EORTC QLQ-C30 and QLQ-BR23 during the 18-week neoadjuvant phase.    Click to Show/Hide
Experiment 24 Reporting the Activity Date of This ADC					[22]
Patients Enrolled	Eligible patients were &ge;18 years with HER2+ breast cancer and measurable untreated intracranial lesions (RANO-BM criteria), &ge;2 weeks post-systemic therapy, and adequate organ function. Exclusions included prior DS-8201a/ADC therapy, recent trial participation, severe comorbidities (lung disease, uncontrolled hypertension/diabetes), or other safety risks per investigator judgment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06361979	Clinical Status	PHASE2
Clinical Description	A Single-arm, Exploratory Clinical Study of SHR-A1811 Combined With Bevacizumab in the Treatment of HER2-positive Breast Cancer With Brain Metastases
Primary Endpoint	The primary endpoint was CNS-ORR, defined as the percentage of participants achieving CNS response per RANO-BM criteria, assessed over up to 2 years.
Other Endpoint	Secondary outcomes included PFS (time to progression or death), ORR (percentage with CR/PR per RECIST 1.1), and AE incidence (proportion with adverse events), all evaluated over up to 2 years.
Experiment 25 Reporting the Activity Date of This ADC					[23]
Patients Enrolled	Key inclusion lab criteria: ANC &ge;1.5&times;10<sup>9</sup>/L, PLT &ge;70&times;10<sup>9</sup>/L, HGB &ge;90g/L, ALT/AST &le;3&times;ULN, and LVEF &ge;50%. Exclusions also cover interstitial lung disease, &ge;4 ADC toxicity, allergies to study drugs, and other factors deemed by investigators to compromise safety or data integrity.
Administration Dosage	Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer SHR-A1811 : 6.4mg/kg , q3w,d1, ivgtt Adebrelimab : 1200mg, q3w,d1, ivgtt
Related Clinical Trial
NCT Number	NCT06411457	Clinical Status	PHASE2
Clinical Description	Single-arm, Multi-center Phase II Clinical Study of SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
Primary Endpoint	The primary endpoint is Overall Response Rate (ORR), assessed every 6 weeks from randomization until first documented progression or death, whichever occurs first, up to 3 years. Secondary endpoints include 3-month Progression-Free Survival (PFS) rate, PFS assessed similarly up to 3 years, Clinical Benefit Rate (CBR), and safety endpoints (incidence of AEs, SAEs, and irAEs).    Click to Show/Hide
Other Endpoint	Eligible participants must be ≥18 years old with ER/PgR ≤10% and low HER2 expression, advanced breast cancer, prior taxane/anthracycline therapy, RECIST 1.1 measurable lesions, ECOG PS 0-1, and adequate organ function. Exclusions include active CNS metastases, prior anti-HER2 ADC treatment, active autoimmune disease, immunosuppressant use, other malignancies, severe ADC-related toxicities, uncontrolled cardiac conditions, active infections, live vaccine receipt within 4 weeks, or psychiatric/substance abuse issues.    Click to Show/Hide
Experiment 26 Reporting the Activity Date of This ADC					[24]
Patients Enrolled	Additional exclusions: interstitial lung disease, uncontrolled cardiovascular conditions, live vaccines within 4 weeks, pregnancy/breastfeeding, or factors compromising study integrity per investigator judgment. Required baseline assessments include ctDNA sampling and negative pregnancy tests for childbearing potential participants.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06433609	Clinical Status	PHASE2
Clinical Description	A Phase II Study of Antibody-Drug Conjugates (ADCs) Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) by investigator assessment, defined as the percentage of evaluable patients achieving CR or PR per RECIST v1.1, measured from randomization until first progression or death, up to 3.5 years. Secondary endpoints include Disease Control Rate (DCR: CR/PR/SD), Clinical Benefit Rate (CBR: CR/PR/SD≥24 weeks), Duration of Response (DoR), Progression-Free Survival (PFS), Overall Survival (OS), and safety (AE incidence).    Click to Show/Hide
Other Endpoint	Eligible patients are females aged 18-75 with HER2-negative advanced breast cancer, ECOG PS 0-1, prior 1-2 lines of systemic therapy (CDK4/6 inhibitor required if HR-positive), ≥1 measurable lesion per RECIST v1.1, stable brain metastases if present, no prior PD- (L)1 inhibitors, and adequate organ function. Exclusion criteria include active/uncontrolled brain metastases, prior anti-HER2/TROP-2 therapy, unresolved third-space fluid, recent antitumor treatments, active autoimmune/immunodeficiency disorders, HBV/HCV infection, immunosuppressant use, second malignancies, or hypersensitivity to study drugs.    Click to Show/Hide
Experiment 27 Reporting the Activity Date of This ADC					[25]
Patients Enrolled	Additional exclusions: systemic immunomodulators within 4 weeks, immunosuppressants (excluding some corticosteroids), allergies to study drugs, concurrent clinical trials, live vaccines within 30 days, transplants, recent childbirth/breastfeeding, substance abuse, or other conditions increasing study risks per investigator judgment.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06592625	Clinical Status	PHASE2
Clinical Description	A Multicenter, Single-arm, Phase 2 Study of Neoadjuvant SHR-A1811 Plus Adebrelimab Injection for Early-stage or Locally Advanced HR Negative or Low Expression/HER2 Low Expression Breast Cancer
Primary Endpoint	Primary endpoints include investigator-assessed tpCR at around 18 weeks post-first dose (post-surgery), ORR pre-surgery, Ki-67 index changes post-surgery, and AEs/SAEs per NCI-CTCAE v5.0 from informed consent until 40-90 days post-treatment.
Other Endpoint	Eligible patients are female, aged 18-75, ECOG 0-1, with stage II/III HR-negative/low HER2+ breast cancer (tumor >2 cm), adequate organ function, and contraception compliance. Exclusions include metastatic/inflammatory breast cancer, prior malignancy (except certain carcinomas), interstitial lung disease, severe CVD, uncontrolled infections, bleeding disorders, or recent anticancer therapies.    Click to Show/Hide
Experiment 28 Reporting the Activity Date of This ADC					[26]
Patients Enrolled	Additional exclusions include recent chemo/radiotherapy (within 3 weeks), uncontrolled effusions, unresolved grade &ge;1 toxicities (excluding alopecia), steroid use (>10mg/day prednisone-equivalent), or conditions deemed high-risk by investigators. Fertile females must use contraception during and for 3 months post-treatment. All participants must provide informed consent and comply with follow-up.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06649331	Clinical Status	PHASE2
Clinical Description	Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer:A Prospective, Open-label, Multicenter, Phase II Trial
Primary Endpoint	The primary efficacy endpoints include ORR (complete/partial response per RECIST 1.1), PFS (time to progression/death), CBR (CR/PR/SD ≥24 weeks), DOR (time from response to progression), OS (time to death up to 5 years), and treatment-related toxicity rate (AEs per CTCAEv5), all measured over a 36-month period except OS.
Other Endpoint	Eligible patients are ≥18 with locally advanced/metastatic breast cancer, prior ADC exposure, measurable disease, and adequate organ function (HB ≥90 g/L, ANC ≥1.5x10^9/L, ALT/AST ≤3-5×ULN, LVEF ≥50%). Key exclusions: uncontrolled CNS metastases, significant heart disease, active HBV/HCV/HIV, recent immunosuppressants, autoimmune diseases, major surgery within 3 weeks, pregnancy/lactation, or other malignancies (except non-melanoma skin/cervical carcinoma in situ).    Click to Show/Hide
Experiment 29 Reporting the Activity Date of This ADC					[27]
Patients Enrolled	Eligible patients require ECOG 0-1, adequate organ function (e.g., ANC &ge;1.5&times;10<sup>9</sup>/L, Hgb &ge;9.0 g/dL, LVEF &ge;50%), and exclusion criteria include untreated CNS metastases, significant cardiac conditions, hypersensitivity to SHR-A1811 components, or gastrointestinal issues impairing drug absorption.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06710990	Clinical Status	PHASE1
Clinical Description	A Multicenter, Open-label, Fixed-sequence Study to Evaluate Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
Primary Endpoint	The study evaluates pharmacokinetic parameters including Cmax and AUC0-16d for SHR-A1811 and its payload, measured during Cycle 2 and Cycle 3 (each lasting 21 days).
Other Endpoint	Additional secondary endpoints include Tmax, t1/2, AUCinf, CL, Vss, and safety assessments (adverse event incidence/severity), tracked from screening until ~3 months post-treatment.
Experiment 30 Reporting the Activity Date of This ADC					[28]
Patients Enrolled	Additional exclusions involve recent anticoagulant use, active malignancies (exceptions: cured cervical/skin cancers), immunodeficiency, uncontrolled HBV/HCV/syphilis, pregnancy/lactation, impaired drug absorption, or investigator-deemed ineligibility. The study prioritizes safety, requiring QTc &le;450/470 msec (M/F) and no allergy to study drugs.
Administration Dosage	In phase Ib, enrolled subjects will received SHR-A1811 combined with pyrotinib at different doses to confirm RP2D and evaluate the safety and tolerance. In phase II, enrolled subjects will received SHR-A1811 combined with pyrotinib and bevacizumab to evaluate the efficacy and safety.
Related Clinical Trial
NCT Number	NCT06718933	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Prospective, Single-arm, Exploratory, Phase Ib/II Study of SHR-A1811 Combined with Pyrotinib and Bevacizumab in Advanced Breast Cancer with Brain Metastasis.
Primary Endpoint	The phase Ib study determines the RP2D based on MTD and subject tolerance, evaluated from first enrollment until Cycle 6 completion, disease progression, or AE-related discontinuation. The phase II primary endpoint is CNS-ORR per RANO-BM, assessed every 6 weeks as the proportion of patients achieving CR/PR.
Other Endpoint	Key inclusion criteria include age >18, ECOG PS 0-2, life expectancy ≥3 months, measurable brain metastases (no prior radiotherapy), stable mannitol/hormone use, adequate organ function, and recovery from prior treatment toxicities (≤G1). Exclusions cover leptomeningeal/cystic metastases, uncontrolled third-space fluid, emergent CNS complications, recent radiotherapy/chemotherapy, unresolved lung disease, bleeding risks, active infections, and significant cardiac/HTN conditions.    Click to Show/Hide
Experiment 31 Reporting the Activity Date of This ADC					[29]
Patients Enrolled	Eligible patients are females aged 18-75 with ECOG 0-2, locally advanced/metastatic breast cancer, no prior systemic therapy, and adequate organ function. Exclusions include uncontrolled diabetes, active infections, prior malignancies (except cured cases), severe comorbidities, pregnancy, or conditions compromising study adherence per investigator judgment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06788197	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Phase Ib/II Study of SHR-A1811 and Fulvestrant in Combination With or Without HS-10352 in Locally Advanced or Metastatic Breast Cancer Patients Who Progressed After Adjuvant Therapy
Primary Endpoint	The study evaluates the Objective Response Rate (ORR) per RECIST v1.1 in the SHR-A1811+fulvestrant and HS-10352 (Phase II) groups over approximately 4 years, defining ORR as the proportion of patients with complete or partial response. Additionally, the Recommended Phase 2 Dose (RP2D) for HS-10352 (Phase Ib) is assessed within a 28-day cycle.
Other Endpoint	Safety and efficacy endpoints include adverse event incidence/severity (CTCAE v5.0), ORR (HS-10352 Phase Ib), Progression-Free Survival (PFS), Overall Survival (OS), Clinical Benefit Rate (CR+PR+SD≥24 weeks), and Duration of Response (DOR) across both treatment groups (Phase Ib/II) over 4 years.
Experiment 32 Reporting the Activity Date of This ADC					[30]
Patients Enrolled	Eligible participants (age 18-75, ECOG 0-1) must have advanced pancreatic cancer with measurable lesions; exclusions include active infections, untreated CNS metastases, uncontrolled comorbidities, recent major surgery, or immunodeficiencies (e.g., HIV, active hepatitis B/C). High pancreatitis risk, recent immunotherapies, or unresolved treatment toxicity also disqualify participation per investigator assessment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06547736	Clinical Status	PHASE2
Clinical Description	A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer
Primary Endpoint	The study assesses the Recommended Phase II Dose (RP2D) based on safety and efficacy data from dose escalation stages over approximately 12 months, alongside Objective Response Rate (ORR) evaluated per RECIST v1.1 during the same timeframe.
Other Endpoint	Secondary endpoints include Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS), all evaluated over a 12-month period. Safety is monitored via adverse events (AEs) graded by NCI-CTCAE v5.0 from first drug administration until 90 days post-last ADC dose.
Experiment 33 Reporting the Activity Date of This ADC					[31]
Patients Enrolled	Eligible patients are HR+/HER2- advanced breast cancer females (&ge;18 years) with prior CDK4/6 inhibitor exposure, measurable lesions, and adequate organ function. Exclusions include recent anticancer therapies (except bisphosphonates), uncontrolled CNS/heart disease, persistent toxicities (&ge;Grade 1), major surgery within 3 weeks, pregnancy, or other malignancies (except cured non-melanoma skin/cervical cancers) in 5 years.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05594095	Clinical Status	PHASE2
Clinical Description	Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study)
Primary Endpoint	The primary endpoint is Overall Response Rate (ORR), defined as the proportion of patients achieving complete or partial remission per RECIST 1.1 criteria, assessed from randomization until disease progression or death over a 3-year study period.
Other Endpoint	Secondary endpoints include Clinical Benefit Rate (CBR: CR+PR+SD lasting ≥24 weeks), Progression-Free Survival (PFS), Overall Survival (OS), safety monitoring via CTCAE v5.0 for 1 year, and exploratory biomarker analysis using tumor/blood/fecal samples to investigate treatment-disease correlations.
Experiment 34 Reporting the Activity Date of This ADC					[32]
Patients Enrolled	Eligible participants are females aged 18-75 with adequate organ function and &ge;12-week life expectancy; exclusions involve active autoimmune/cardiovascular diseases, recent thromboembolic events, gastrointestinal obstruction, immunocompromised status, or other investigator-determined risks to trial integrity.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06859775	Clinical Status	PHASE1|||PHASE2
Clinical Description	Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Primary Endpoint	The primary endpoints include Grade ≥3 treatment-related adverse events (TRAEs) and serious adverse events (SAEs) over 3 years, alongside objective response rate (ORR) evaluating tumor shrinkage per RECIST criteria.
Other Endpoint	Secondary outcomes comprise duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS), all measured over a 3-year follow-up period.
Experiment 35 Reporting the Activity Date of This ADC					[33]
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1) must have unresectable/metastatic biliary tract cancer, &ge;1 measurable lesion, adequate organ function, and HBV-DNA <500 IU/mL if HBV+. Exclusions cover recent anticancer therapies (<4 weeks), CNS metastases, severe comorbidities (cardiac/hepatic/pancreatic disorders, uncontrolled effusions), active infections, or thromboembolic events within 6 months.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06413745	Clinical Status	PHASE2
Clinical Description	A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v1.1 criteria over approximately one year.
Other Endpoint	Secondary endpoints include Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS) evaluated by IRC and researchers (RECIST v1.1, ~1 year), plus Overall Survival (OS, ~2 years) and safety measures (AEs/SAEs, ~1 year).
Experiment 36 Reporting the Activity Date of This ADC					[34]
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1) must have newly diagnosed locally advanced/metastatic biliary tract cancer with &ge;1 measurable lesion and adequate organ function. Key exclusions: concurrent malignancies, recent local therapy (<4 weeks), biliary obstruction, active autoimmune/interstitial lung diseases, uncontrolled HBV, or severe cardiovascular conditions.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06778031	Clinical Status	PHASE2
Clinical Description	An Open, Multicenter Phase II Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Primary Endpoint	The primary endpoint is investigator-assessed Objective Response Rate (ORR) for the SHR-A1811 combination therapy, evaluated during screening through study completion over an average of 3 years per RECIST v1.1 criteria.
Other Endpoint	Secondary outcomes include investigator-assessed DoR, DCR, PFS, and OS for the SHR-A1811 combination (3-year average), alongside adverse events (AEs) monitoring throughout the study period.
Experiment 37 Reporting the Activity Date of This ADC					[35]
Patients Enrolled	Eligible patients must have RAS/RAF wild-type metastatic colorectal cancer (post-oxaliplatin/5-FU/irinotecan &plusmn; anti-PD-1/PD-L1 failure for DMMR/MSI-H), &ge;1 measurable lesion (RECIST 1.1), ECOG 0-1, and adequate organ function. Exclusions: active infections (HBV DNA &ge;500 IU/mL, HCV+), uncontrolled effusions, recent major surgery/immunosuppressants (>10 mg prednisone/day), CNS metastases, or other malignancies within 5 years (excl. non-melanoma skin/cervical carcinoma in situ).    Click to Show/Hide
Administration Dosage	SHR-A1811 (4.8 mg/kg) was administered intravenously on the first day of each cycle, once every 3 weeks (Q3W)
Related Clinical Trial
NCT Number	NCT06199973	Clinical Status	PHASE3
Clinical Description	Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
Primary Endpoint	The primary endpoint is Independent Review Committee (IRC)-assessed Progression-Free Survival (PFS), evaluated every 6 weeks for up to 3 years.
Other Endpoint	Secondary endpoints include safety (adverse events monitored per cycle, 21-28 days) and investigator-assessed efficacy measures: PFS, Objective Response Rate (ORR), Duration of Response (DoR), and Overall Survival (OS), all tracked every 6 weeks over 3 years.
Experiment 38 Reporting the Activity Date of This ADC					[36]
Patients Enrolled	Eligible participants (18-75 years, ECOG 0-1, life expectancy >3 months) must have histologically confirmed unresectable/metastatic gastric/GEJ adenocarcinoma (Cohorts A/B) with &ge;1 measurable lesion (RECIST 1.1) and adequate organ function (ANC &ge;1.5&times;10<sup>9</sup>/L, PLT &ge;100&times;10<sup>9</sup>/L, LVEF &ge;50%, etc.). Exclusions: untreated/active CNS metastases, uncontrolled effusions, prior topoisomerase I inhibitor ADC therapy (e.g., DS-8201), immunosuppressants (>10 mg/day prednisone within 14 days), unresolved Grade >1 toxicities (excluding alopecia), active HBV/HCV infection, severe cardiovascular disease, or uncontrolled infections (IV antibiotics within 2 weeks).    Click to Show/Hide
Administration Dosage	SHR-A1811 injection will be administered by intravenous infusion. And apatinib will be administered orally.
Related Clinical Trial
NCT Number	NCT06666166	Clinical Status	PHASE2
Clinical Description	Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR), assessed from baseline up to 6 months, to evaluate antitumor efficacy.
Other Endpoint	Secondary endpoints include Duration of Response (DOR) and Overall Survival (OS) (baseline up to 12 months), Disease Control Rate (DCR) and Progression-Free Survival (PFS) (baseline up to 6 months), and incidence of Treatment-Emergent Adverse Events (from first dose to 28 days post-last dose) to assess safety and tolerability.
Experiment 39 Reporting the Activity Date of This ADC					[37]
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1, HER2+, life expectancy &ge;3 months) must have locally advanced/metastatic gastric/GEJ adenocarcinoma-Phase Ib: prior treatment failure/intolerance; Phase II: treatment-na&iuml;ve. Exclusions: uncontrolled effusions, recent major surgery (4 weeks), active autoimmunity, interstitial pneumonia, recent severe infection (4 weeks), tuberculosis (1 year), cardiovascular risks, or recent GI perforation/fistula (6 months).    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05671822	Clinical Status	PHASE2
Clinical Description	A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Primary Endpoint	The Phase Ib study evaluates safety through DLT rates, AEs, and SAEs (assessed over 24 months post-consent), while Phase II primarily measures ORR (average 12-month follow-up).
Other Endpoint	Secondary endpoints include ORR, DOR, PFS (all Phase Ib: 12-18 months), OS (Phase Ib: 30 months); Phase II assesses DOR/PFS (18 months), OS (30 months), and AEs/SAEs (24 months post-consent). Safety remains a cross-phase priority.
Experiment 40 Reporting the Activity Date of This ADC					[38]
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1) must have metastatic NSCLC, measurable lesions, organ function adequacy, and failed standard therapy. Exclusions involve active CNS metastases, recent antitumor therapies, uncontrolled comorbidities, autoimmune/cardiac diseases, infections, pregnancy, or conditions affecting drug absorption/compliance per investigator judgment. Tissue samples are mandatory.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05482568	Clinical Status	PHASE1|||PHASE2
Clinical Description	Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2
Primary Endpoint	The Phase I (dose exploration phase) primary endpoints include DLT (assessed 21 days post-first administration), AE, and SAE incidence/severity (both tracked for two years post-last enrollment). The Phase II (efficacy expansion stage) primary endpoint is objective response rate (evaluated over two years post-last enrollment).
Other Endpoint	Phase I/II secondary endpoints comprise immunogenicity markers (toxin-binding/total/neutralizing antibodies for SHR-A1811/SHR-1316), pharmacokinetic parameters (free toxin SHR169265, pyrotinib, SHR-1316 plasma concentrations), and efficacy outcomes (ORR, DoR, PFS). All assessments span two years post-last enrollment.
Experiment 41 Reporting the Activity Date of This ADC					[39]
Patients Enrolled	Eligible patients (18-75 years, ECOG 0-1) must have HER2-mutated advanced/metastatic NSCLC without prior systemic treatment, measurable lesions (RECIST 1.1), and adequate organ function. Exclusions include mixed histology, additional driver mutations (with approved targeted drugs), untreated CNS metastases, uncontrolled pain, concurrent malignancies, interstitial pneumonia, autoimmune/cardiovascular diseases, or active hepatitis B/C.    Click to Show/Hide
Administration Dosage	Drug: SHR-A1811 administered intravenously every 3 weeks (Q3W)
Related Clinical Trial
NCT Number	NCT06430437	Clinical Status	PHASE3
Clinical Description	A Randomized, Open-Label, Multicenter Phase III Study of SHR-A1811 for First-Line Treatment in Subjects With HER2-Mutated Advanced or Metastatic Non-Small Cell Lung Cancer
Primary Endpoint	The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review (BICR) per RECIST 1.1, measured from randomization until progression (evaluation period up to 2 years).
Other Endpoint	Secondary endpoints include overall survival (OS) (until death, up to 3 years), investigator-assessed PFS (up to 2 years per RECIST 1.1), and incidence/severity of AEs/SAEs (graded by CTCAE v5.0, tracked until 90 days post-last dose, up to 3 years).
Experiment 42 Reporting the Activity Date of This ADC					[40]
Patients Enrolled	Eligible subjects must provide informed consent, have measurable disease per RECIST v1.1, ECOG 0-1 performance status, and &ge;12-week life expectancy. Exclusions comprise active CNS metastases, uncontrolled cardiovascular/autoimmune diseases, active hepatitis B/C, severe infections, and tuberculosis.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06828354	Clinical Status	PHASE3
Clinical Description	An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR-A1811 Versus Investigator-selected Chemotherapy for Platinum-resistant Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Primary Endpoint	The primary endpoint is progression-free survival (PFS) evaluated from day 1 of treatment up to 10 months.
Other Endpoint	Key secondary endpoints include objective response rate (ORR), disease control rate (DCR), duration of response (DOR), overall survival (OS), and response rate (RR) (all assessed from day 1 to 12 months), along with monitoring adverse events (AEs) until 40 days post-last dose.
Experiment 43 Reporting the Activity Date of This ADC					[41]
Patients Enrolled	Eligible participants must provide informed consent, supply tumor tissue for testing, have measurable lesions per RECIST v1.1, an ECOG PS of 0-1, and expected survival &ge;12 weeks. Key exclusions involve uncontrolled CNS metastases, symptomatic effusions, interstitial lung disease, poorly managed hypertension, serious infections, immune deficiency, or other factors compromising study integrity.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06840002	Clinical Status	PHASE1|||PHASE2
Clinical Description	An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
Primary Endpoint	The study evaluates dose-limited toxicity (DLT) and recommended Phase II dose (RP2D) within 21 days, alongside objective response rate (ORR) assessed every 9 weeks over approximately one year.
Other Endpoint	Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and standard response rate (RR), all monitored every 9 weeks for about one year. Overall survival (OS) is tracked for around 3 years post-enrollment, while adverse events (AEs) and serious adverse events (SAEs) are recorded from first dose to 90 days post-treatment.    Click to Show/Hide
Experiment 44 Reporting the Activity Date of This ADC					[42]
Patients Enrolled	Eligible patients must be &ge;18 years old with measurable lesions per RECIST 1.1, ECOG 0-1, life expectancy &ge;12 weeks, and adequate organ function. Exclusions include untreated brain/meningeal metastases, symptomatic effusions requiring drainage, prior malignancies (within 5 years), uncontrolled cardiovascular/autoimmune diseases, active hepatitis, unresolved treatment-related toxicities (CTCAE >1), and recent GI obstruction/perforation.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05349409	Clinical Status	PHASE2
Clinical Description	A Phase Ib/II Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients
Primary Endpoint	The study evaluates dose-limiting toxicity (DLT) and determines the recommended Phase II dose (RP2D) of SHR-A1811 combined with Fluzoparib within 21 days. Objective response rate (ORR) is assessed based on RECIST v1.1, measured from treatment initiation to disease progression or alternative therapy, up to 6 months.
Other Endpoint	Secondary endpoints include duration of response (DoR), disease control rate (DCR), time to recovery (TTR), progression-free survival (PFS), and overall survival (OS) up to 100 months, along with 12-month survival rate. Safety endpoints track AEs/SAEs per CTCAE v5.0 and dose modifications due to toxicity. Pharmacokinetics (PK) parameters (Cmin, C3h, Cmax, AUC0-t) and immunogenicity (ADA, NAb) of SHR-A1811 and Fluzoparib are monitored over defined periods.    Click to Show/Hide
Experiment 45 Reporting the Activity Date of This ADC					[43]
Patients Enrolled	Eligibility requires age 18-75, ECOG 0-1, HER2-positive advanced/metastatic solid tumors, measurable lesions, and adequate organ function. Key exclusions include active CNS/meningeal metastases, prior HER2 ADC/ TKI use, unresolved toxicities >CTCAE G2, active ILD, uncontrolled infections (HBV/HCV/HIV), recent major surgery, allergies to study drugs, pregnancy, or uncontrolled comorbidities (e.g., hypertension, thrombosis risk). Part B1 further excludes G2+ neuropathy or BP102-related bleeding/thrombosis risks.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06015048	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
Primary Endpoint	Part A (Phase IB) assesses the maximally tolerated dose (MTD), recommended phase 2 dose (RP2D), adverse events (AEs), and objective response rate (ORR) within 11 months. ORR is evaluated per RECIST v1.1 from treatment initiation to disease progression or last dose.
Other Endpoint	Secondary endpoints include disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety (assessed per CTCAE) in both Phase IB and Phase II, with follow-up periods up to 13 months.
Experiment 46 Reporting the Activity Date of This ADC					[44]
Efficacy Data	Objective Response Rate (ORR)	61.60 81.50 55.80 %
Patients Enrolled	Pts were eligible if they had HER2 positive breast cancer (BC), HER2 positive gastric/GEJ carcinoma, HER2 low-expressing BC, HER2-expressing/mutated NSCLC, or other HER2-expressing/mutated solid tumors, and were refractory or intolerant to standard therapy.
Administration Dosage	SHR-A1811 at doses of 1.00-8.00 mg/kg was given Q3W (IV).
Related Clinical Trial
NCT Number	NCT04446260	Clinical Status	Phase 1
Clinical Description	A phase 1 multi-country, multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A1811 in HER2 expressing or mutated advanced malignant solid tumor subjects.
Experiment 47 Reporting the Activity Date of This ADC					[45]
Related Clinical Trial
NCT Number	NCT05424835	Clinical Status	Phase 3
Clinical Description	A phase 3, multicenter, randomized, open-label, parallel controlled study of SHR-A1811 versus pyrotinib in combination with capecitabine for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Experiment 48 Reporting the Activity Date of This ADC					[46]
Related Clinical Trial
NCT Number	NCT05594095	Clinical Status	Phase 2
Clinical Description	Precision platform study of HR+/ HER2-advanced breast cancer based on snf typing (a prospective, open-label, multi-center, phase 2 platform study).
Experiment 49 Reporting the Activity Date of This ADC					[47]
Related Clinical Trial
NCT Number	NCT05749588	Clinical Status	Phase 2
Clinical Description	Precision platform study of refractory triple-negative breast cancer based on molecular subtyping (a phase 2, open-label, single-center platform study).
Experiment 50 Reporting the Activity Date of This ADC					[48]
Related Clinical Trial
NCT Number	NCT05769010	Clinical Status	Phase 2
Clinical Description	A prospective, open-label explorative study of SHR-A1811 in HER2-expression advanced breast cancer with brain metastases.
Experiment 51 Reporting the Activity Date of This ADC					[49]
Related Clinical Trial
NCT Number	NCT05353361	Clinical Status	Phase 2
Clinical Description	A phase 1b/2 multicenter, open-label clinical trial of SHR-A1811 injection in combination with pyrotinib or pertuzumab or SHR-1316 or paclitaxel for injection (albumin bound) in HER2-positive breast cancer.
Experiment 52 Reporting the Activity Date of This ADC					[50]
Related Clinical Trial
NCT Number	NCT05671822	Clinical Status	Phase 2
Clinical Description	A phase 1b/2 study of SHR-A1811 combinations in patients with advanced/metastatic HER2+ gastric /gastroesophageal junction adenocarcinoma.
Experiment 53 Reporting the Activity Date of This ADC					[51]
Related Clinical Trial
NCT Number	NCT05635487	Clinical Status	Phase 2
Clinical Description	A single-arm, phase 2 study of SHR-A1811 combined with pyrotinib maleate as neoadjuvant treatment in HER2-positive breast cancer patients.
Experiment 54 Reporting the Activity Date of This ADC					[52]
Related Clinical Trial
NCT Number	NCT05349409	Clinical Status	Phase 2
Clinical Description	A phase 1b/2 clinical study on the dosage exploration and efficiency expansion of SHR-A1811 for injection in combination with fluzoparib capsule in HER2-expressing advanced solid tumors of patients.
Experiment 55 Reporting the Activity Date of This ADC					[53]
Related Clinical Trial
NCT Number	NCT05582499	Clinical Status	Phase 1/2
Clinical Description	Fudan university shanghai cancer center breast cancer precision platform series study- neoadjuvant therapy (FASCINATE-N).
Experiment 56 Reporting the Activity Date of This ADC					[54]
Related Clinical Trial
NCT Number	NCT05482568	Clinical Status	Phase 1/2
Clinical Description	Phase 1B/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of injectable SHR-A1811 in combination with pyrotinib or SHR-1316 in subjects with advanced non-small cell lung cancer with HER2.
Experiment 57 Reporting the Activity Date of This ADC					[55]
Related Clinical Trial
NCT Number	NCT04818333	Clinical Status	Phase 1/2
Clinical Description	Phase 1/2 clinical study of the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression, amplification, or mutation.
Experiment 58 Reporting the Activity Date of This ADC					[56]
Related Clinical Trial
NCT Number	NCT04513223	Clinical Status	Phase 1
Clinical Description	Safety, tolerability, pharmacokinetics, and antitumour activity of SHR-A1811, in patients with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer: a phase 1 study.

Experiment 1 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	0.42 ± 0.10 nM	High HER2 expression (HER2+++)
Method Description	The cytotoxicity of SHR169265 was evaluated in SK-BR-3 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 2 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	0.57 ± 0.15 nM	High HER2 expression (HER2+++)
Method Description	The cytotoxicity of SHR169265 was evaluated in NCI-N87 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 3 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	0.77 ± 0.10 nM	High HER2 expression (HER2+++)
Method Description	The cytotoxicity of SHR169265 was evaluated in HCC1954 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 4 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	11.3 ± 2.7 nM	Low HER2expression (HER2+)
Method Description	The cytotoxicity of SHR169265 was evaluated in CaPAN-1 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 5 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	42.5 ± 7.8 nM	Low HER2expression (HER2+)
Method Description	The cytotoxicity of SHR169265 was evaluated in MKN45 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 6 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	59.1 ± 17.2 nM	Low HER2expression (HER2+)
Method Description	The cytotoxicity of SHR169265 was evaluated in AGS cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 7 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	97.3 ± 23.1 nM	Negative HER2 expression (HER2-)
Method Description	The cytotoxicity of SHR169265 was evaluated in MDA-MB-468 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 8 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	132.6 nM	Low HER2expression (HER2+)
Method Description	The cytotoxicity of SHR169265 was evaluated in SNU-16 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434
Experiment 9 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Half Maximal inhibitory Concentration (lC50)	302.9 ± 87 nM	Moderate HER2 expression (HER2++)
Method Description	The cytotoxicity of SHR169265 was evaluated in JIMT-1 cell lines.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434

Ref 1	SHR-A1811 (antibody-drug conjugate) in advanced HER2-mutant non-small cell lung cancer: a multicenter, open-label, phase 1/2 study
Ref 2	SHR-A1811, a novel anti-HER2 antibody-drug conjugate with optimal drug-to-antibody ratio, superior bystander killing effect and favorable safety profiles
Ref 3	First disclosure of AZD5335, a TOP1i-ADC targeting low and high FR-expressing ovarian cancer with superior preclinical activity vs FR-MTI ADC. Cancer Res (2023) 83 (8_Supplement): LB025.
Ref 4	A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
Ref 5	A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Ref 6	A Study of SHR-A1811 in Subjects With Gynaecologic Oncology
Ref 7	A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
Ref 8	A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
Ref 9	Study of SHR-A1811 in HER2-expression Advanced Breast Cancer with Brain Metastases
Ref 10	A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Ref 11	A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients
Ref 12	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
Ref 13	A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
Ref 14	A Phase Ib/II Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
Ref 15	SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
Ref 16	Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer(GALAXY)
Ref 17	A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.
Ref 18	A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
Ref 19	A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
Ref 20	Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer
Ref 21	SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Ref 22	SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases
Ref 23	SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
Ref 24	Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
Ref 25	Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
Ref 26	Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer
Ref 27	Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer
Ref 28	Study of SHR-A1811 Combined with Pyrotinib and Bevacizumab in Advanced Breast Cancer with Brain Metastasis
Ref 29	A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients
Ref 30	Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer
Ref 31	SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Ref 32	SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
Ref 33	Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Ref 34	A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer
Ref 35	Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan
Ref 36	SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
Ref 37	Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
Ref 38	A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
Ref 39	A Study of SHR-A1811 in First-line Treatment of Patients With Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Mutations
Ref 40	A Study of SHR-A1811 in Subjects With Ovarian Cancer
Ref 41	A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer
Ref 42	A Trial of the Combination of SHR-A1811 and Fluzoparib in HER2-Expressing Cancers
Ref 43	A Trial of SHR-A1811 Combined With Other Antitumor Therapies in Advanced Solid Tumors.
Ref 44	A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects, NCT04446260
Ref 45	A Phase III, Multicenter, Randomized, Open-Label, Parallel Controlled Study of SHR-A1811 Versus Pyrotinib in Combination With Capecitabine for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane, NCT05424835
Ref 46	Precision Platform Study of HR+/ HER2-advanced Breast Cancer Based on SNF Typing (A Prospective, Open-label, Multi-center, Phase II Platform Study), NCT05594095
Ref 47	Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping(A Phase II, Open-label, Single-center Platform Study, NCT05749588
Ref 48	A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases, NCT05769010
Ref 49	A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or SHR-1316 or Paclitaxel for Injection (Albumin Bound) in HER2-Positive Breast Cancer, NCT05353361
Ref 50	A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2+ Gastric /Gastroesophageal Junction Adenocarcinoma, NCT05671822
Ref 51	A Single-arm, Phase II Study of SHR-A1811 Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients, NCT05635487
Ref 52	A Phase b/ Clinical Study on the Dosage Exploration and Efficiency Expansion of SHR-A1811 for Injection in Combination With Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients, NCT05349409
Ref 53	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N), NCT05582499
Ref 54	Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2, NCT05482568
Ref 55	Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation, NCT04818333
Ref 56	Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study, NCT04513223