Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0SZKXH)

ADC Name	BYON3521
Synonyms	BYON3521 Click to Show/Hide
Organization	Byondis (Originator)
Drug Status	Phase 1
Drug-to-Antibody Ratio	1.8
Structure
	3D MOL	2D MOL
Antibody Name	SYD2884		Antibody Info
Antigen Name	Hepatocyte growth factor receptor (MET)		Antigen Info
Payload Name	Seco-DUBA		Payload Info
Payload Target	Human deoxyribonucleic acid (hDNA)		Target Info
Linker Name	Mal-PEG2-Val-Cit-PABA-Cyclization Spacer		Linker Info
Conjugate Type	Reactive Cysteines
Combination Type	duocarmazine

2027 Update

The disease landscape of This ADC

2027 Update

The clinical trial pipelines of This ADC

Disease Name

Phase 1

Phase 2

Phase 3

Approved

Pancreatic cancer

1 Trials

Clinical trial identifier
NCT05323045

Lung cancer

1 Trials

Clinical trial identifier
NCT05323045

Melanoma

1 Trials

Clinical trial identifier
NCT05323045

Ovarian cancer

1 Trials

Clinical trial identifier
NCT05323045

Endometrial cancer

1 Trials

Clinical trial identifier
NCT05323045

Cervical cancer

1 Trials

Clinical trial identifier
NCT05323045

Unspecific solid tumor

1 Trials

Clinical trial identifier
NCT05323045

2027 Update

ADC-specific functional property

Bystander Killing Effect

Click To Hide/Show 2 ADC-specific functional property Data

Bystander Killing Effect	Description	Reference
yes	The cleavability of the vc-seco-DUBA linker-drug, combined with cell permeability of the toxin, gives BYON3521 the intrinsic capacity to kill neighboring MET-negative tumor cells as well, also referred to as bystander activity. Cocultured MET-negative Jurkat NucLight Red and MET-positive tumor cells (1:1 ratio) were treated with BYON3521 and proliferation of Jurkat NucLight Red cells was followed in time. In those cocultures, BYON3521 was able to induce not only cell death in MET-positive cells, but also induced cell killing of the MET-negative Jurkat NucLight Red cells Click to Show/Hide	[1]
yes	The cleavability of the vc-seco-DUBA linker-drug, combined with cell permeability of the toxin, gives BYON3521 the intrinsic capacity to kill neighboring MET-negative tumor cells as well, also referred to as bystander activity. Cocultured MET-negative Jurkat NucLight Red and MET-positive tumor cells (1:1 ratio) were treated with BYON3521 and proliferation of Jurkat NucLight Red cells was followed in time. In those cocultures, BYON3521 was able to induce not only cell death in MET-positive cells, but also induced cell killing of the MET-negative Jurkat NucLight Red cells. Click to Show/Hide	[1]

2027 Update

General Information of The ADMET Data Related to This ADC

Absorption

Click To Hide/Show 62 Absorption Data Related to This Level

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (C_max)	132	ug/mL	5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.	[1]
Area Under the Concentration-Time Curve (AUC)	9520	ug·h/mL	5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.	[1]
Maximum Observed Concentration (C_max)	4.85	ug/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.	[1]
Maximum Observed Concentration (C_max)	11.7	ug/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.	[1]
Maximum Observed Concentration (C_max)	46.5	ug/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg.	[1]
Maximum Observed Concentration (C_max)	130	ug/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg.	[1]
Maximum Observed Concentration (C_max)	4.96	ug/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg.	[1]
Maximum Observed Concentration (C_max)	19	ug/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.	[1]
Maximum Observed Concentration (C_max)	57.4	ug/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.	[1]
Maximum Observed Concentration (C_max)	187	ug/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg.	[1]
Maximum Observed Concentration (C_max)	21.8	ug/mL	Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg.	[1]
Maximum Observed Concentration (C_max)	32	ug/mL	Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	896	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	2330	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	7500	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 3 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	32300	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 10 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	355	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 0.3 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	1670	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	5920	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	33900	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 10 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	4020	ug·h/mL	Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 1 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	7980	ug·h/mL	Mean BYON3521 PK parameters in MAXF574 mouse PDX models, 3 mg/kg, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	1040	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	2910	ug·h/mL	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1700	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	6850	ug·h/mL	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg, AUCinf.	[1]
Maximum Observed Concentration (C_max)	132	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	132	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.	[1]
Maximum Observed Concentration (C_max)	169	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	190	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.	[1]
Maximum Observed Concentration (C_max)	371	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	390	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.	[1]
Maximum Observed Concentration (C_max)	676	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	659	ug/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.	[1]
Area Under the Concentration-Time Curve (AUC)	9520	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	9760	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	18200	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	19600	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	43100	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	39200	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	77300	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	78900	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	9670	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1070	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	18500	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	19800	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	45600	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	42100	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	89100	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	88600	ug·h/mL	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female, AUCinf.	[1]
Maximum Observed Concentration (C_max)	115	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	128	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female.	[1]
Maximum Observed Concentration (C_max)	467	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	445	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female.	[1]
Maximum Observed Concentration (C_max)	742	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male.	[1]
Maximum Observed Concentration (C_max)	737	ug/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female.	[1]
Area Under the Concentration-Time Curve (AUC)	9450	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	10300	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	62400	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	53600	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	101000	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male, AUClast.	[1]
Area Under the Concentration-Time Curve (AUC)	116000	ug·h/mL	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female, AUClast.	[1]

Distribution

Click To Hide/Show 13 Distribution Data Related to This Level

Standard Type	Value	Units	Description	Reference
Volume of Distribution (V_d)	47.9	mL/kg	5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.	[1]
Volume of Distribution (V_d)	74.5	mL/h/kg	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.	[1]
Volume of Distribution (V_d)	108	mL/h/kg	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.	[1]
Volume of Distribution (V_d)	73.8	mL/h/kg	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.	[1]
Volume of Distribution (V_d)	104	mL/h/kg	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.	[1]
Volume of Distribution (V_d)	47.9	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.	[1]
Volume of Distribution (V_d)	47.9	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.	[1]
Volume of Distribution (V_d)	54	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.	[1]
Volume of Distribution (V_d)	45.6	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.	[1]
Volume of Distribution (V_d)	66.2	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.	[1]
Volume of Distribution (V_d)	60.8	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.	[1]
Volume of Distribution (V_d)	57.8	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.	[1]
Volume of Distribution (V_d)	67.1	mL/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.	[1]

Excretion

Click To Hide/Show 31 Excretion Data Related to This Level

Standard Type	Value	Units	Description	Reference
Elimination Half-Life (t_1/2)	60.7	h	5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.	[1]
Clearance (CL)	0.519	mL/h/kg	5 Mg/kg BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion.	[1]
Elimination Half-Life (t_1/2)	181	h	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.	[1]
Elimination Half-Life (t_1/2)	221	h	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.	[1]
Elimination Half-Life (t_1/2)	87.5	h	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.	[1]
Clearance (CL)	0.287	mL/h/kg	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 0.3 mg/kg.	[1]
Clearance (CL)	0.344	mL/h/kg	Mean BYON3521 PK parameters in HNXF1905 mouse PDX models, 1 mg/kg.	[1]
Clearance (CL)	0.59	mL/h/kg	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 1 mg/kg.	[1]
Clearance (CL)	0.438	mL/h/kg	Mean BYON3521 PK parameters in LXFL1176 mouse PDX models, 3 mg/kg.	[1]
Elimination Half-Life (t_1/2)	60.7	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	69.1	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	93.2	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	78	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	143	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	125	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	152	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	172	h	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.	[1]
Clearance (CL)	0.519	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Male.	[1]
Clearance (CL)	0.467	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 5 mg/kg, Female.	[1]
Clearance (CL)	0.378	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Male.	[1]
Clearance (CL)	0.354	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 7 mg/kg, Female.	[1]
Clearance (CL)	0.342	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Male.	[1]
Clearance (CL)	0.357	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 15 mg/kg, Female.	[1]
Clearance (CL)	0.304	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Male.	[1]
Clearance (CL)	0.295	mL/h/kg	Mean BYON3521 single dose PK parameters in cynomolgus monkey GLP study after first infusion, 25 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	74.7	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	74.4	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 5 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	172	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	170	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 15 mg/kg, Female.	[1]
Elimination Half-Life (t_1/2)	134	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Male.	[1]
Elimination Half-Life (t_1/2)	237	h	Mean BYON3521 repeat dose PK parameters in cynomolgus monkey GLP study after the fourth IV (Q3W) infusion of BYON3521, 25 mg/kg, Female.	[1]

General Information of The Activity Data Related to This ADC

Identified from the Human Clinical Data

Click To Hide/Show 2 Activity Data Related to This Level

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Undisclosed	NCT05323045	PHASE1	A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours Click to Show/Hide
Undisclosed	NCT05323045	Phase 1	A first-in-human dose-escalation and expansion trial with the antibody-drug conjugate BYON3521 to evaluate the safety, pharmacokinetics and efficacy in patients with c-met expressing locally advanced or metastatic solid tumours. Click to Show/Hide

Full List of Activity Data of This Antibody-drug Conjugate

Identified from the Human Clinical Data

Click To Hide/Show 2 Activity Data Related to This Level

Experiment 1 Reporting the Activity Date of This ADC				[2]
Patients Enrolled	Eligible patients must have advanced/metastatic c-MET-positive tumors (confirmed by IHC/dISH/mutation) refractory to standard therapy, ECOG ≤1, and adequate organ function. Key exclusions include prior SYD985 treatment, recent anticancer therapy (<4 weeks), active pneumonitis/cardiovascular disease, or untreated/symptomatic brain metastases. Keratitis and glomerulonephritis history also preclude participation. Click to Show/Hide
Administration Dosage	BYON3521 (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.
*Related Clinical Trial*
NCT Number	NCT05323045	Clinical Status	PHASE1
Clinical Description	A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours
Primary Endpoint	The study evaluates safety in Part 1 (dose-escalation) by monitoring dose-limiting toxicities (DLTs) during the first 21-day cycle to determine the maximum tolerated dose (MTD).
Other Endpoint	Efficacy in Part 2 (expansion cohorts) is assessed via objective response rate (ORR) at 21-day intervals across four tumor types: non-squamous NSCLC (Cohort A), gynecological cancers (B), pancreatic adenocarcinoma (C), and uveal melanoma (D), all requiring c-MET overexpression (IHC ≥2+).
Experiment 2 Reporting the Activity Date of This ADC				[3]
Patients Enrolled	Patients with previously treated progressive locally advanced or metastatic solid tumors, MET positive.
Administration Dosage	.
*Related Clinical Trial*
NCT Number	NCT05323045	Clinical Status	Phase 1
Clinical Description	A first-in-human dose-escalation and expansion trial with the antibody-drug conjugate BYON3521 to evaluate the safety, pharmacokinetics and efficacy in patients with c-met expressing locally advanced or metastatic solid tumours.

References

Ref 1	Preclinical Profile of BYON3521 Predicts an Effective and Safe MET Antibody-Drug Conjugate
Ref 2	A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521
Ref 3	A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects with Metastatic Breast Cancer NCT05261269. Cancer Res (2023) 83 (5_Supplement): OT3-28-01.

Antibody-drug Conjugate Information

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Correspondence

Prof. Feng ZHU (zhufeng@zju.edu.cn)

Prof. Xiaowu DONG (dongxw@zju.edu.cn)

Prof. Luo FANG (fangluo@zjcc.org.cn)