ADC ID	DRG0ELYWP
ADC Name	Tusamitamab ravtansine
Synonyms	tusamitamab ravtansine; SAR408701; SAR-408701; IBI-126    Click to Show/Hide
Organization	ImmunoGen (Top20 MNC) (Originator) (No Rights);Sanofi (Top20 MNC);Innovent Biologics
Drug Status	Phase 3 (discontinued)
Drug-to-Antibody Ratio	~3.8
Structure
				2D MOL
Antibody Name	Tusamitamab					Antibody Info
Antigen Name	Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5)					Antigen Info
Payload Name	DM4					Payload Info
Therapeutic Target	Microtubule (MT)					Target Info
Linker Name	N-succinimidyl 4-(2-pyridyldithio) butanoate (SPDB)					Linker Info
Conjugate Type	Random Lysines
Combination Type	ravtansine

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (Cmax)	4.58	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Maximum Observed Concentration (Cmax)	14.1	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Maximum Observed Concentration (Cmax)	21.1±2.47	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Maximum Observed Concentration (Cmax)	46.2±7.76	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Maximum Observed Concentration (Cmax)	45.6±3.13	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Maximum Observed Concentration (Cmax)	57.4±9.18	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Maximum Observed Concentration (Cmax)	84.2±9.14	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Time to Maximum Concentration (Tmax)	0.01	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Time to Maximum Concentration (Tmax)	0.01	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Time to Maximum Concentration (Tmax)	0.01	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Time to Maximum Concentration (Tmax)	0.04	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Time to Maximum Concentration (Tmax)	0.04	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Time to Maximum Concentration (Tmax)	0.1	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Time to Maximum Concentration (Tmax)	0.05	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	23.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	55.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	101±4.78	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, AUC0-14d, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	218±57.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	204±57.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, AUC0-14d, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	267±105	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, AUC0-14d, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	419±58.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	28.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	68.6	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	124±8.70	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	276±89.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	243±86.7	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	322±149	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	581±151	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Maximum Observed Concentration (Cmax)	53.8±13.7	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Maximum Observed Concentration (Cmax)	64.9±23.5	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Maximum Observed Concentration (Cmax)	90.1±25.2	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Maximum Observed Concentration (Cmax)	101±18.5	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Time to Maximum Concentration (Tmax)	0.05	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Time to Maximum Concentration (Tmax)	0.2	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Time to Maximum Concentration (Tmax)	0.06	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Time to Maximum Concentration (Tmax)	0.06	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	316±92.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	334±45	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, AUC0-14d, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	445±40.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, AUC0-14d, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	576±162	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	423±221	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	422±60.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	563±68.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	773±247	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Maximum Observed Concentration (Cmax)	66.6±8.7	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Maximum Observed Concentration (Cmax)	76.6±14.5	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Maximum Observed Concentration (Cmax)	84.7±25.2	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Maximum Observed Concentration (Cmax)	98.7±4.59	ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Time to Maximum Concentration (Tmax)	0.05	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Time to Maximum Concentration (Tmax)	0.22	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Time to Maximum Concentration (Tmax)	0.07	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Time to Maximum Concentration (Tmax)	0.07	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	394±55.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	441±167	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, AUC0-14d, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	526±139	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	669±126	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	452±90.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	606±200	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	590±164	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	775±207	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Maximum Observed Concentration (Cmax)	40.1±8.90	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	51.0±11.9	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	71.6±14.5	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	80.2±9.87	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	97.1±26.7	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	93.8±10.9	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Maximum Observed Concentration (Cmax)	80.5±13.0	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.04	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.13	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.12	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.13	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.17	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.06	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Time to Maximum Concentration (Tmax)	0.14	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	183±127	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	301±94.4	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	308±120	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	363±154	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	444±125	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	593±142	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	475±162	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	210±173	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	387±146	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	372±198	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	359±250	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	535±240	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	688±182	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	549±236	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	23.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	55.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	101±4.78	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, AUC0-14d, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	218±57.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	204±57.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, AUC0-14d, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	267±105	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, AUC0-14d, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	419±58.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	28.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	68.6	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	124±8.70	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	276±89.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	243±86.7	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	322±149	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	581±151	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Volume of Distribution (Vd)	5.05	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Volume of Distribution (Vd)	3.97	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Volume of Distribution (Vd)	3.83±0.344	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Volume of Distribution (Vd)	4.22±0.489	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Volume of Distribution (Vd)	4.88±0.819	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Volume of Distribution (Vd)	4.91±1.12	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Volume of Distribution (Vd)	4.56±0.258	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	316±92.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	334±45	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, AUC0-14d, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	445±40.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, AUC0-14d, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	576±162	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	423±221	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	422±60.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	563±68.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	773±247	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Volume of Distribution (Vd)	5.35±0.985	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Volume of Distribution (Vd)	3.74±0.626	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Volume of Distribution (Vd)	4.57±0.782	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Volume of Distribution (Vd)	4.02±0.951	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	394±55.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	441±167	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, AUC0-14d, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	526±139	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	669±126	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	452±90.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	606±200	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	590±164	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	775±207	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Volume of Distribution (Vd)	4.02±0.908	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Volume of Distribution (Vd)	4.81±0.736	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Volume of Distribution (Vd)	4.54±1.67	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Volume of Distribution (Vd)	3.68±0.989	L	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
End-of-Infusion Concentration (Ceoi)	38.3±10.4	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	49.8±13.2	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	68.8±12.3	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	73.9±11.5	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	74.7±12.1	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	87.9±13.1	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
End-of-Infusion Concentration (Ceoi)	77.6±15.8	ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	183±127	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	301±94.4	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	308±120	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	363±154	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	444±125	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	593±142	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	475±162	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	210±173	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	387±146	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	372±198	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	359±250	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	535±240	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	688±182	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	549±236	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Volume of Distribution (Vd)	3.18±0.788	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Volume of Distribution (Vd)	3.93±0.936	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Volume of Distribution (Vd)	4.19±0.441	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Volume of Distribution (Vd)	3.18±0.674	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Volume of Distribution (Vd)	4.32±0.641	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Volume of Distribution (Vd)	3.56±1.67	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Volume of Distribution (Vd)	4.54±0.904	L	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	23.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	55.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	101±4.78	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, AUC0-14d, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	218±57.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	204±57.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, AUC0-14d, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	267±105	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, AUC0-14d, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	419±58.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	28.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	68.6	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	124±8.70	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	276±89.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	243±86.7	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	322±149	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	581±151	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	316±92.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	334±45	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, AUC0-14d, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	445±40.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, AUC0-14d, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	576±162	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	423±221	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	422±60.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	563±68.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	773±247	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	394±55.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	441±167	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, AUC0-14d, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	526±139	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	669±126	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	452±90.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	606±200	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	590±164	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	775±207	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	183±127	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	301±94.4	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	308±120	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	363±154	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	444±125	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	593±142	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	475±162	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	210±173	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	387±146	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	372±198	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	359±250	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	535±240	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	688±182	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	549±236	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	23.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	55.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, AUC0-14d, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	101±4.78	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, AUC0-14d, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	218±57.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	204±57.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, AUC0-14d, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	267±105	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, AUC0-14d, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	419±58.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, AUC0-14d, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	28.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	68.6	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Area Under the Concentration-Time Curve (AUC)	124±8.70	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Area Under the Concentration-Time Curve (AUC)	276±89.8	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	243±86.7	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Area Under the Concentration-Time Curve (AUC)	322±149	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Area Under the Concentration-Time Curve (AUC)	581±151	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Elimination Half-Life (t1/2)	5.84	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Elimination Half-Life (t1/2)	5.99	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Elimination Half-Life (t1/2)	6.00±0.38	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Elimination Half-Life (t1/2)	6.29±1.11	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Elimination Half-Life (t1/2)	5.15±1.51	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Elimination Half-Life (t1/2)	4.93±1.90	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Elimination Half-Life (t1/2)	7.70±1.68	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Clearance (CL)	0.655	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 10 mg/m2, N=1.	[1]
Clearance (CL)	0.505	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 20 mg/m2, N=1.	[1]
Clearance (CL)	0.486±0.0090	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 40 mg/m2, N=2.	[1]
Clearance (CL)	0.516±0.0689	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 80 mg/m2, N=3.	[1]
Clearance (CL)	0.823±0.358	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 100 mg/m2, N=5.	[1]
Clearance (CL)	0.973±0.683	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 120 mg/m2, N=9.	[1]
Clearance (CL)	0.463±0.0933	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1, 150 mg/m2, N=3.	[1]
Area Under the Concentration-Time Curve (AUC)	316±92.5	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	334±45	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, AUC0-14d, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	445±40.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, AUC0-14d, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	576±162	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	423±221	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	422±60.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Area Under the Concentration-Time Curve (AUC)	563±68.2	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Area Under the Concentration-Time Curve (AUC)	773±247	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Elimination Half-Life (t1/2)	8.39±2.61	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Elimination Half-Life (t1/2)	6.3±2.5	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Elimination Half-Life (t1/2)	7.35±1.53	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Elimination Half-Life (t1/2)	7.13±1.01	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Clearance (CL)	0.670±0.370	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 120 mg/m2, N=3.	[2]
Clearance (CL)	0.546±0.118	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 135 mg/m2, N=4.	[2]
Clearance (CL)	0526±0.0476	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 150 mg/m2, N=7.	[2]
Clearance (CL)	0.435±0.166	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=12.	[2]
Area Under the Concentration-Time Curve (AUC)	394±55.1	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	441±167	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, AUC0-14d, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	526±139	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, AUC0-14d, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	669±126	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, AUC0-14d, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	452±90.9	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	606±200	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Area Under the Concentration-Time Curve (AUC)	590±164	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Area Under the Concentration-Time Curve (AUC)	775±207	day*ug/mL	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Elimination Half-Life (t1/2)	6.88±1.94	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Elimination Half-Life (t1/2)	7.7±1.4	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Elimination Half-Life (t1/2)	6.72±0.922	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Elimination Half-Life (t1/2)	6.6±0.872	day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Clearance (CL)	0.489±0.143	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 120 mg/m2, N=3.	[2]
Clearance (CL)	0.502±0.181	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 150 mg/m2, N=2.	[2]
Clearance (CL)	0.532±0.183	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q2W-LD), 170 mg/m2, N=6.	[2]
Clearance (CL)	0.431±0.0952	L/day	Plasma pharmacokinetics of tusamitamab ravtansine on Cycle 1 (cohort Q3W), 190 mg/m2, N=3.	[2]
Area Under the Concentration-Time Curve (AUC)	183±127	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	301±94.4	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	308±120	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	363±154	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	444±125	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	593±142	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	475±162	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2, AUCtau.	[3]
Area Under the Concentration-Time Curve (AUC)	210±173	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	387±146	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	372±198	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	359±250	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	535±240	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	688±182	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Area Under the Concentration-Time Curve (AUC)	549±236	day*ug/mL	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Elimination Half-Life (t1/2)	3.44±2.30	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Elimination Half-Life (t1/2)	6.96±1.53	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Elimination Half-Life (t1/2)	4.87±2.18	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Elimination Half-Life (t1/2)	6.76±4.18	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Elimination Half-Life (t1/2)	6.90±2.60	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Elimination Half-Life (t1/2)	7.56±1.57	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Elimination Half-Life (t1/2)	6.54±2.41	day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]
Clearance (CL)	0.942±0.755	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 80 mg/m2.	[3]
Clearance (CL)	0.513±0.27	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Main dose escalation part Q2W, 100 mg/m2.	[3]
Clearance (CL)	0.736±0.294	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 135 mg/m2.	[3]
Clearance (CL)	1.02±0.651	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 150 mg/m2.	[3]
Clearance (CL)	0.712±0.551	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation bis part Q2W, 170 mg/m2.	[3]
Clearance (CL)	0.363±0.117	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 150 mg/m2.	[3]
Clearance (CL)	0.647±0.359	L/day	Tusamitamab ravtansine PK parameters on Cycle 1 for all three parts, Dose escalation Q3W part, 170 mg/m2.	[3]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
stable disease (SD)	NCT05245071	PHASE2	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA    Click to Show/Hide
Partial Response (PR)	NCT05245071	PHASE2	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA    Click to Show/Hide
Objective Response Rate (ORR)	NCT05245071	PHASE2	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA    Click to Show/Hide
Objective Response Rate (ORR)	NCT04394624	PHASE2	Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Tusamitamab Ravtansine (SAR408701) Used in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Metastatic, Non-squamous, Non Small-cell Lung Cancer (NSQ NSCLC) Patients With CEACAM5-positive Tumors, Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor    Click to Show/Hide
Objective Response Rate (ORR)	NCT02187848	PHASE1	A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors
Objective Response Rate (ORR)	NCT04524689	PHASE2	Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)    Click to Show/Hide
Disease control rate (DCR)	NCT05245071	PHASE2	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA    Click to Show/Hide
Disease control rate (DCR)	NCT04394624	PHASE2	Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Tusamitamab Ravtansine (SAR408701) Used in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Metastatic, Non-squamous, Non Small-cell Lung Cancer (NSQ NSCLC) Patients With CEACAM5-positive Tumors, Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor    Click to Show/Hide
Disease control rate (DCR)	NCT04524689	PHASE2	Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)    Click to Show/Hide
Undisclosed	NCT04659603	PHASE2	Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
Undisclosed	NCT05429762	PHASE1	Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors
Undisclosed	NCT03324113	PHASE1	A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors
Undisclosed	NCT05071053	PHASE2	Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors    Click to Show/Hide
Undisclosed	NCT05703555	PHASE2	INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Undisclosed	NCT04154956	PHASE3	Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors
Objective Response Rate (ORR)	NCT04524689	Phase 2	Open-label, phase 2 study of tusamitamab ravtansine (SAR408701) combined with pembrolizumab and tusamitamab ravtansine (SAR408701) combined with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with CEACAM5 positive expression advanced/metastatic non-squamous non-small-cell lung cancer (nsq NSCLC).    Click to Show/Hide
Objective Response Rate (ORR)	NCT02187848	Phase 1	A first-in-human study for the evaluation of the safety, pharmacokinetics and antitumor activity of SAR408701 in patients with advanced solid tumors.
Undisclosed	NCT05703555	Phase 2	Intrusion: unraveling the intratumoral PK/PD relation for SAR408701.
Undisclosed	NCT04659603	Phase 2	Open-label, multi-cohort, phase 2 trial, evaluating the efficacy and safety of tusamitamab ravtansine (SAR408701) monotherapy and in combination in patients with CEACAM5-positive advanced solid tumors.    Click to Show/Hide
Undisclosed	NCT05071053	Phase 2	Open-label study of tusamitamab ravtansine (SAR408701) in combination with ramucirumab in participants previously treated for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with CEACAM5-positive tumors.    Click to Show/Hide
Undisclosed	NCT05245071	Phase 2	Open-label, phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous non-small-cell lung cancer (nsq NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating CEA.    Click to Show/Hide
Undisclosed	NCT03324113	Phase 1	A phase 1 study to evaluate safety and pharmacokinetics of SAR408701 administered intravenously as monotherapy in japanese patients with advanced malignant solid tumors.
Undisclosed	NCT04154956	Phase 1	Randomized, open-label, phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors.
Undisclosed	NCT05429762	Phase 1	Open-label study evaluating the effect of tusamitamab ravtansine on the QTC interval in participants with metastatic solid tumors.

Standard Type	Value	Units	Animal Model (No. of PDX)
Tumor Growth Inhibition value (TGI)	0	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Tumor Growth Inhibition value (TGI)	6.4	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	27.1	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	32.9	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	41.5	%	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Tumor Growth Inhibition value (TGI)	55	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	57.2	%	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Tumor Growth Inhibition value (TGI)	60.3	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Tumor Growth Inhibition value (TGI)	63.9	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Tumor Growth Inhibition value (TGI)	66.2	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Tumor Growth Inhibition value (TGI)	69.7	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	69.8	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Tumor Growth Inhibition value (TGI)	70.2	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	71.8	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Tumor Growth Inhibition value (TGI)	76.5	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	84.7	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Tumor Growth Inhibition value (TGI)	90.2	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Tumor Growth Inhibition value (TGI)	90.3	%	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Tumor Growth Inhibition value (TGI)	91.4	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	92.4	%	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Tumor Growth Inhibition value (TGI)	92.8	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Tumor Growth Inhibition value (TGI)	92.8	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Tumor Growth Inhibition value (TGI)	93.3	%	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Tumor Growth Inhibition value (TGI)	93.5	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	97	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Tumor Growth Inhibition value (TGI)	99.4	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	99.9	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Tumor Growth Inhibition value (TGI)	100	%	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximal Inhibitory Concentration (IC50)	0.20±0.04	nM	HPAF-II cells	Pancreatic ductal adenocarcinoma
Half Maximal Inhibitory Concentration (IC50)	0.38±0.07	nM	HPAF-II cells	Pancreatic ductal adenocarcinoma
Half Maximal Inhibitory Concentration (IC50)	1.08±0.17	nM	MKN45 cells	Gastric adenocarcinoma

Experiment 1 Reporting the Activity Date of This ADC					[4]
Efficacy Data	stable disease (SD)	27.30%
Patients Enrolled	Key inclusion criteria: metastatic NSQ NSCLC patients (post-platinum/IO) with moderate/negative CEACAM5 expression (IHC 2+ in 1-50% or 1+ tumors) plus CEA ≥100 ng/mL, measurable lesions, ECOG 0-1. Major exclusions: untreated CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved grade ≥2 toxicity (except alopecia/vitiligo), corneal disorders, contact lens use, or poor organ function. Reproductive-age participants require contraception.    Click to Show/Hide
Administration Dosage	Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Related Clinical Trial
NCT Number	NCT05245071	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Primary Endpoint	The study assesses efficacy through Objective Response Rate (ORR), defined as the percentage of participants achieving confirmed complete response (CR, disappearance of all target lesions and lymph nodes <10mm) or partial response (PR, ≥30% reduction in target lesion sum) per RECIST v1.1, evaluated at baseline and every 8 weeks (±7 days) over approximately 46 weeks.    Click to Show/Hide
Other Endpoint	Safety analyses include treatment-emergent adverse events (TEAEs/SAEs) recorded from first dose until primary completion (~21 months). Secondary efficacy endpoints - Progression-Free Survival (PFS), Disease Control Rate (DCR), and Duration of Response (DOR) - all follow RECIST v1.1 criteria, with PD requiring ≥20% (minimum 5mm absolute) increase in target lesions or new lesions, assessed every 8 weeks over 46 weeks.    Click to Show/Hide
Experiment 2 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Partial Response (PR)	9.10%
Patients Enrolled	Key inclusion criteria: metastatic NSQ NSCLC patients (post-platinum/IO) with moderate/negative CEACAM5 expression (IHC 2+ in 1-50% or 1+ tumors) plus CEA &ge;100 ng/mL, measurable lesions, ECOG 0-1. Major exclusions: untreated CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved grade &ge;2 toxicity (except alopecia/vitiligo), corneal disorders, contact lens use, or poor organ function. Reproductive-age participants require contraception.    Click to Show/Hide
Administration Dosage	Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Related Clinical Trial
NCT Number	NCT05245071	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Primary Endpoint	The study assesses efficacy through Objective Response Rate (ORR), defined as the percentage of participants achieving confirmed complete response (CR, disappearance of all target lesions and lymph nodes <10mm) or partial response (PR, ≥30% reduction in target lesion sum) per RECIST v1.1, evaluated at baseline and every 8 weeks (±7 days) over approximately 46 weeks.    Click to Show/Hide
Other Endpoint	Safety analyses include treatment-emergent adverse events (TEAEs/SAEs) recorded from first dose until primary completion (~21 months). Secondary efficacy endpoints - Progression-Free Survival (PFS), Disease Control Rate (DCR), and Duration of Response (DOR) - all follow RECIST v1.1 criteria, with PD requiring ≥20% (minimum 5mm absolute) increase in target lesions or new lesions, assessed every 8 weeks over 46 weeks.    Click to Show/Hide
Experiment 3 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Objective Response Rate (ORR)	9.10%
Patients Enrolled	Key inclusion criteria: metastatic NSQ NSCLC patients (post-platinum/IO) with moderate/negative CEACAM5 expression (IHC 2+ in 1-50% or 1+ tumors) plus CEA &ge;100 ng/mL, measurable lesions, ECOG 0-1. Major exclusions: untreated CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved grade &ge;2 toxicity (except alopecia/vitiligo), corneal disorders, contact lens use, or poor organ function. Reproductive-age participants require contraception.    Click to Show/Hide
Administration Dosage	Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Related Clinical Trial
NCT Number	NCT05245071	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Primary Endpoint	The study assesses efficacy through Objective Response Rate (ORR), defined as the percentage of participants achieving confirmed complete response (CR, disappearance of all target lesions and lymph nodes <10mm) or partial response (PR, ≥30% reduction in target lesion sum) per RECIST v1.1, evaluated at baseline and every 8 weeks (±7 days) over approximately 46 weeks.    Click to Show/Hide
Other Endpoint	Safety analyses include treatment-emergent adverse events (TEAEs/SAEs) recorded from first dose until primary completion (~21 months). Secondary efficacy endpoints - Progression-Free Survival (PFS), Disease Control Rate (DCR), and Duration of Response (DOR) - all follow RECIST v1.1 criteria, with PD requiring ≥20% (minimum 5mm absolute) increase in target lesions or new lesions, assessed every 8 weeks over 46 weeks.    Click to Show/Hide
Experiment 4 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Objective Response Rate (ORR)	19.40%
Patients Enrolled	Eligibility required metastatic disease progression post-platinum chemotherapy and PD-1/PD-L1 inhibitors, CEACAM5 expression &ge;2+, measurable lesions (RECIST v1.1), and ECOG 0-1. Exclusion criteria included untreated brain metastases, major comorbidities, active infections, uncontrolled hypertension, prior treatments targeting CEACAM5 or maytansinoids, and severe organ dysfunction. Specific Triplet Cohort exclusions included autoimmune diseases, transplant history, interstitial lung disease, or recent live vaccines.    Click to Show/Hide
Administration Dosage	CARMEN-LC04 is an open-label phase 2 study (NCT04394624) assessing combination tusa rav 100 mg/m2 every 2 weeks (Q2W) + ram 8 mg/kg Q2W in patients with mNSQ NSCLC and high CEACAM5 expression (≥2+ intensity in ≥50% of tumor cells by immunohistochemistry).
Related Clinical Trial
NCT Number	NCT04394624	Clinical Status	PHASE2
Clinical Description	Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Tusamitamab Ravtansine (SAR408701) Used in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Metastatic, Non-squamous, Non Small-cell Lung Cancer (NSQ NSCLC) Patients With CEACAM5-positive Tumors, Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor
Primary Endpoint	The study involves evaluating dose-limiting toxicities (DLTs) in both Doublet (Part 1 and 2) and Triplet Cohorts, including grade 4 neutropenia, thrombocytopenia, non-hematologic AEs, keratopathy, and refractory hypertension. Key efficacy measures include objective response rate (ORR) in the Doublet Cohort (Part 2) and Triplet Cohort, calculated per RECIST v1.1 criteria for solid tumors.    Click to Show/Hide
Other Endpoint	Safety assessments covered treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities in lab parameters, ECG, and urinalysis. Efficacy endpoints in the Doublet Cohort included duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR). Pharmacokinetic parameters such as Cmax, AUC0-14d, and Ctrough were analyzed for tusamitamab ravtansine and ramucirumab. Immunogenicity was assessed via anti-therapeutic antibodies (ATAs).    Click to Show/Hide
Experiment 5 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Objective Response Rate (ORR)	20.3 7.1 %
Patients Enrolled	Participants had advanced CEACAM5+ cancers (CRC/NSCLC/gastric favored; CEA >5ng/mL accepted). Mandatory criteria: measurable disease (expansion phase), archived tumor tissue, and biopsy consent (CRC/gastric cohorts). Exclusions included active CNS metastases, unresolved ocular/cardiac disorders (LVEF<50%), prior CEACAM5/DM1/DM4 therapy, strong CYP3A inhibitor use, or contraindications to ophthalmic medications (glaucoma/hypertension/allergies). Reproductive-age patients required contraception for &ge;3 months post-treatment.    Click to Show/Hide
Administration Dosage	In cohort Q2W-LD, 38 patients were screened for eligibility and 28 patients were enrolled and treated with tusamitamab ravtansine across four LD-DLs ranging from 120 to 170 mg/m2 between March 13, 2017, and February 17, 2020, at study sites in Canada, France, Republic of Korea, and Spain (Table 1). In cohort Q3W, 21 patients were screened for eligibility and 15 patients were enrolled and initiated treatment with tusamitamab ravtansine across four DLs ranging from 120 to 190 mg/m2 between July 15, 2019, and October 20, 2020, at study sites in Canada, France, and Spain (Table 1).    Click to Show/Hide
Related Clinical Trial
NCT Number	NCT02187848	Clinical Status	PHASE1
Clinical Description	A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors
Primary Endpoint	The study assessed dose-limiting toxicities (DLTs) over 4-week (Q2W) or 3-week (Q3W) cycles alongside tumor response rates per RECIST 1.1 criteria during a 40-month follow-up period.
Other Endpoint	Key evaluations included safety monitoring (TEAEs over 4 years), pharmacokinetics (Cmax, tmax, AUC0-14d/21d, CL/CLss, Rac over 2 months), immunogenicity (anti-SAR408701 antibodies), and efficacy endpoints (DOR, TTP assessed every 6-8 weeks for 40 months).
Experiment 6 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Objective Response Rate (ORR)	40%
Patients Enrolled	Eligible participants had advanced/metastatic NSQ NSCLC (no EGFR/BRAF/ALK/ROS mutations), CEACAM5 expression &ge;2+, measurable disease (RECIST 1.1), and ECOG 0-1. Exclusions included uncontrolled brain metastases, active infections, autoimmune diseases, prior anti-PD-1/PD-L1 therapy, recent live vaccines, significant allergies, or unresolved toxicities (&ge;Grade 2). Prior chemotherapy for metastatic disease or CEACAM5-targeted treatments was prohibited.    Click to Show/Hide
Administration Dosage	Pembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Related Clinical Trial
NCT Number	NCT04524689	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Primary Endpoint	Across all cohorts, dose-limiting toxicities (DLTs) included severe hematologic (grade 4 neutropenia, febrile neutropenia, thrombocytopenia) and non-hematologic events (grade 4 AEs, keratopathy) observed during Cycle 1. Efficacy endpoints assessed in Doublet and Quadruplet Cohorts included objective response rate (ORR), defined per RECIST v1.1 as confirmed complete (CR) or partial response (PR), with CR requiring disappearance of target lesions and PR a ≥30% reduction in lesion sum diameters.    Click to Show/Hide
Other Endpoint	Safety assessments covered treatment-emergent adverse events (TEAEs) and serious AEs (TESAEs). Key efficacy measures included progression-free survival (PFS), disease control rate (DCR), and duration of response (DOR) across cohorts, evaluated via RECIST v1.1 criteria. Pharmacokinetic parameters (Ctrough, Ceoi) were measured for tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin. Immunogenicity was assessed via anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine.    Click to Show/Hide
Experiment 7 Reporting the Activity Date of This ADC					[4]
Efficacy Data	Disease control rate (DCR)	36.40%
Patients Enrolled	Key inclusion criteria: metastatic NSQ NSCLC patients (post-platinum/IO) with moderate/negative CEACAM5 expression (IHC 2+ in 1-50% or 1+ tumors) plus CEA &ge;100 ng/mL, measurable lesions, ECOG 0-1. Major exclusions: untreated CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved grade &ge;2 toxicity (except alopecia/vitiligo), corneal disorders, contact lens use, or poor organ function. Reproductive-age participants require contraception.    Click to Show/Hide
Administration Dosage	Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Related Clinical Trial
NCT Number	NCT05245071	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Primary Endpoint	The study assesses efficacy through Objective Response Rate (ORR), defined as the percentage of participants achieving confirmed complete response (CR, disappearance of all target lesions and lymph nodes <10mm) or partial response (PR, ≥30% reduction in target lesion sum) per RECIST v1.1, evaluated at baseline and every 8 weeks (±7 days) over approximately 46 weeks.    Click to Show/Hide
Other Endpoint	Safety analyses include treatment-emergent adverse events (TEAEs/SAEs) recorded from first dose until primary completion (~21 months). Secondary efficacy endpoints - Progression-Free Survival (PFS), Disease Control Rate (DCR), and Duration of Response (DOR) - all follow RECIST v1.1 criteria, with PD requiring ≥20% (minimum 5mm absolute) increase in target lesions or new lesions, assessed every 8 weeks over 46 weeks.    Click to Show/Hide
Experiment 8 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Disease control rate (DCR)	83.90%
Patients Enrolled	Eligibility required metastatic disease progression post-platinum chemotherapy and PD-1/PD-L1 inhibitors, CEACAM5 expression &ge;2+, measurable lesions (RECIST v1.1), and ECOG 0-1. Exclusion criteria included untreated brain metastases, major comorbidities, active infections, uncontrolled hypertension, prior treatments targeting CEACAM5 or maytansinoids, and severe organ dysfunction. Specific Triplet Cohort exclusions included autoimmune diseases, transplant history, interstitial lung disease, or recent live vaccines.    Click to Show/Hide
Administration Dosage	CARMEN-LC04 is an open-label phase 2 study (NCT04394624) assessing combination tusa rav 100 mg/m2 every 2 weeks (Q2W) + ram 8 mg/kg Q2W in patients with mNSQ NSCLC and high CEACAM5 expression (≥2+ intensity in ≥50% of tumor cells by immunohistochemistry).
Related Clinical Trial
NCT Number	NCT04394624	Clinical Status	PHASE2
Clinical Description	Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Tusamitamab Ravtansine (SAR408701) Used in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Metastatic, Non-squamous, Non Small-cell Lung Cancer (NSQ NSCLC) Patients With CEACAM5-positive Tumors, Previously Treated With Platinum-based Chemotherapy and an Immune Checkpoint Inhibitor
Primary Endpoint	The study involves evaluating dose-limiting toxicities (DLTs) in both Doublet (Part 1 and 2) and Triplet Cohorts, including grade 4 neutropenia, thrombocytopenia, non-hematologic AEs, keratopathy, and refractory hypertension. Key efficacy measures include objective response rate (ORR) in the Doublet Cohort (Part 2) and Triplet Cohort, calculated per RECIST v1.1 criteria for solid tumors.    Click to Show/Hide
Other Endpoint	Safety assessments covered treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant abnormalities in lab parameters, ECG, and urinalysis. Efficacy endpoints in the Doublet Cohort included duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR). Pharmacokinetic parameters such as Cmax, AUC0-14d, and Ctrough were analyzed for tusamitamab ravtansine and ramucirumab. Immunogenicity was assessed via anti-therapeutic antibodies (ATAs).    Click to Show/Hide
Experiment 9 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Disease control rate (DCR)	88%
Patients Enrolled	Eligible participants had advanced/metastatic NSQ NSCLC (no EGFR/BRAF/ALK/ROS mutations), CEACAM5 expression &ge;2+, measurable disease (RECIST 1.1), and ECOG 0-1. Exclusions included uncontrolled brain metastases, active infections, autoimmune diseases, prior anti-PD-1/PD-L1 therapy, recent live vaccines, significant allergies, or unresolved toxicities (&ge;Grade 2). Prior chemotherapy for metastatic disease or CEACAM5-targeted treatments was prohibited.    Click to Show/Hide
Administration Dosage	Pembrolizumab dose will be administered intravenously prior to intravenous administration of tusamitamab ravtansine dose every 3 weeks.
Related Clinical Trial
NCT Number	NCT04524689	Clinical Status	PHASE2
Clinical Description	Open-label, Phase 2 Study of Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) Combined With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With CEACAM5 Positive Expression Advanced/Metastatic Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Primary Endpoint	Across all cohorts, dose-limiting toxicities (DLTs) included severe hematologic (grade 4 neutropenia, febrile neutropenia, thrombocytopenia) and non-hematologic events (grade 4 AEs, keratopathy) observed during Cycle 1. Efficacy endpoints assessed in Doublet and Quadruplet Cohorts included objective response rate (ORR), defined per RECIST v1.1 as confirmed complete (CR) or partial response (PR), with CR requiring disappearance of target lesions and PR a ≥30% reduction in lesion sum diameters.    Click to Show/Hide
Other Endpoint	Safety assessments covered treatment-emergent adverse events (TEAEs) and serious AEs (TESAEs). Key efficacy measures included progression-free survival (PFS), disease control rate (DCR), and duration of response (DOR) across cohorts, evaluated via RECIST v1.1 criteria. Pharmacokinetic parameters (Ctrough, Ceoi) were measured for tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin. Immunogenicity was assessed via anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine.    Click to Show/Hide
Experiment 10 Reporting the Activity Date of This ADC					[7]
Patients Enrolled	Eligible participants required &ge;18 years, measurable lesions (RECIST v1.1), ECOG 0-1, CEACAM5+ tumors, and metastatic disease. Cohort-specific criteria: mBC (Cohort A) needed 2-4 prior chemotherapy lines; mPAC (Cohorts B/C) required progression after gemcitabine/5-FU regimens (B) or 1st-line fluoropyrimidine (C). Key exclusions: active infections (HIV/hepatitis), untreated brain metastases, unresolved Grade &ge;2 toxicities, corneal disorders, prior CEACAM5/DM4 therapy, major surgery <2 weeks, or inadequate organ function. Cohort C additionally excluded prior taxane/gemcitabine exposure.    Click to Show/Hide
Administration Dosage	tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV)
Related Clinical Trial
NCT Number	NCT04659603	Clinical Status	PHASE2
Clinical Description	Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
Primary Endpoint	The primary focus was evaluating Objective Response Rate (ORR) across cohorts (A:26.1w, B:51.6w, C:43.3w), defined as confirmed CR (complete lesion disappearance) or PR (≥30% target lesion reduction) per RECIST v1.1. Dose-limiting toxicities (DLTs) in Cohort C included Grade 4 neutropenia ≥7 days, Grade 3-4 neutropenia with infection, ≥Grade 3 thrombocytopenia with bleeding, Grade 4 non-hematologic AEs, or Grade ≥3 keratopathy during Cycle 1 (28 days).    Click to Show/Hide
Other Endpoint	Secondary outcomes included TEAEs/TESAEs (up to 150 weeks), lab abnormalities (hematology/chemistry per NCI CTCAE v5.0), PFS (time to progression/death), DCR (CR+PR+SD), DOR (response duration), ATAs against tusamitamab ravtansine, and PK parameters (Cmax, AUC0-14d, CL for tusamitamab/gemcitabine/dFdU in Cohort C during Cycle 1). Assessments spanned treatment exposure periods specific to each cohort.    Click to Show/Hide
Experiment 11 Reporting the Activity Date of This ADC					[8]
Patients Enrolled	Eligible participants had metastatic CRC (CEACAM5+ assumed), NSQ NSCLC (CEACAM5+/high CEA), or GC/GEJ (CEACAM5+), ECOG 0-1. Key exclusions: active brain metastases, unresolved corneal disorders, QTcF >480 msec, significant comorbidities, or prior QT-prolonging drugs unless stabilized pre-study.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT05429762	Clinical Status	PHASE1
Clinical Description	Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors
Primary Endpoint	The study evaluates the change from baseline in QTcF interval and other ECG parameters (HR, QT, QTcB, QRS, PR) to assess cardiac effects of tusamitamab ravtansine during Cycles 1-2 (each cycle=2 weeks).
Other Endpoint	Key assessments include PK parameters (Cmax, AUC0-14d) in Cycle 1, safety monitoring (TEAEs/SAEs per NCI CTCAE v5.0 for ~34 weeks), and efficacy outcomes (ORR/DOR per RECIST v1.1 assessed for ~30 weeks).
Experiment 12 Reporting the Activity Date of This ADC					[9]
Patients Enrolled	Eligible patients had CEACAM5+ advanced solid tumors (archival tissue required) with no standard alternatives. Exclusions: ECOG &ge;2, active CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved corneal disorders, strong CYP3A inhibitor use (unless discontinued &ge;2 weeks pre-dose), or inadequate contraception. Reproductive-age participants required contraception for 6 months post-treatment.    Click to Show/Hide
Administration Dosage	SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors
Related Clinical Trial
NCT Number	NCT03324113	Clinical Status	PHASE1
Clinical Description	A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors
Primary Endpoint	The study evaluates IMP-related dose-limiting toxicities (DLTs) graded per NCI-CTC v4.03 over a 4-week period (3 weeks for q3w dose-escalation), requiring validation by the Study Committee when unrelated to disease progression.
Other Endpoint	Key assessments include treatment-emergent AEs (over ~9 months) and PK parameters (Cmax, Tmax, AUC for SAR408701/DM4/Me-DM4) analyzed during specific cycles (14-day Q2W or 21-day Q3W dosing). Additional outcomes comprise CEACAM5 plasma levels (PDy effect), RECIST 1.1 tumor responses, and immunogenicity (anti-SAR408701 antibodies) over ~10 months.
Experiment 13 Reporting the Activity Date of This ADC					[10]
Patients Enrolled	Eligible participants had CEACAM5-high metastatic/unresectable gastric/GEJ adenocarcinoma (measurable lesions, ECOG 0-1). Key exclusions: untreated CNS metastases, prior CEACAM5/DM1/DM4 therapy, unresolved corneal disorders, recent thrombotic/hemorrhagic events (within 2-6 months), uncontrolled hypertension, or CYP3A inhibitor use. Reproductive-age participants required contraception (7 months post-treatment for females, 4 for males).    Click to Show/Hide
Administration Dosage	Participants received ramucirumab 8 milligram/kilogram (mg/kg) via intravenous (IV) infusion followed by tusamitamab ravtansine loading dose at 170 mg/meter square (m^2) via IV infusion on Cycle 1 Day 1 (each cycle was 2 weeks); and then ramucirumab 8 mg/kg via IV infusion followed by tusamitamab ravtansine 100 mg/m^2 via IV infusion at Cycle 2 and every 2 weeks (Q2W) in all subsequent cycles until disease progression, unacceptable adverse event (AE), death, initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment.    Click to Show/Hide
Related Clinical Trial
NCT Number	NCT05071053	Clinical Status	PHASE2
Clinical Description	Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors
Primary Endpoint	The study assessed dose-limiting toxicities (DLTs) during the first 28 days, defined as grade 4 neutropenia ≥7 days, febrile neutropenia, significant thrombocytopenia with bleeding, grade 4 non-hematologic AEs, or grade ≥3 keratopathy. Objective response rate (ORR) was evaluated per RECIST v1.1 as the percentage of participants achieving complete or partial response based on tumor assessments every 6 weeks.    Click to Show/Hide
Other Endpoint	Safety outcomes included treatment-emergent AEs (TEAEs/TESAEs) up to 30 days post-treatment (~92 weeks). Efficacy endpoints comprised duration of response (DOR), progression-free survival (PFS), and disease control rate (DCR) assessed via RECIST v1.1. Pharmacokinetic analysis measured Ctrough for tusamitamab ravtansine and ramucirumab, alongside antitherapeutic antibody (ATA) detection against tusamitamab ravtansine.    Click to Show/Hide
Experiment 14 Reporting the Activity Date of This ADC					[11]
Patients Enrolled	Eligible patients (&ge;18y, ECOG 0-1) have CEACAM5+ (&ge;2+ in 50% cells) metastatic NSCLC (post-chemo/IO), ER+ breast cancer (hormone-refractory), or gastric cancer (exhausted SOC). Key exclusions: untreated brain metastases, recent thromboembolism (<6mo), CYP3A modulator use, unresolved grade &ge;2 toxicity (except alopecia), prior CEACAM5/DM4 therapy, corneal disorders, or contact lens use. Required organ function: ANC &ge;1.5x109/L, platelets &ge;100x109/L, eGFR &ge;50mL/min, and serum albumin &ge;25g/L. Reproductive-age participants must use contraception (females: 7 months post-treatment; males: 4 months).    Click to Show/Hide
Administration Dosage	Tusamitamab ravtansine 100 mg/m2 IV Q2W
Related Clinical Trial
NCT Number	NCT05703555	Clinical Status	PHASE2
Clinical Description	INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Primary Endpoint	The study measures intratumoral DM4 and tusamitamab ravtansine concentrations via PK assay on Cycle 2 Day 3 (~5 weeks). Additional pharmacodynamic assessments include CEACAM5 expression changes (IHC), RNA sequencing (DESeq2), tumor microenvironment analysis (quanTIseq/TIL signatures), somatic genomic profiling (WGS), and circulating CEA levels tracked every 8 weeks for up to 2 years. PK parameters (AUCinf, Cmax, Tmax) are evaluated through serial plasma sampling across cycles.    Click to Show/Hide
Other Endpoint	Safety monitoring records CTCAE v5.0 grade 3-4 AEs during treatment (≤2 years), while efficacy is assessed per RECIST v1.1 for PD/SD/PR/CR every 8 weeks. Systemic PK analysis quantifies tusamitamab ravtansine (clearance, volume), DM4 metabolites (Lys-SPDB-DM4, Me-DM4), and calculates Thalf (ln (2)/Lambda z) using trapezoidal AUC methods from baseline through Cycle 4.    Click to Show/Hide
Experiment 15 Reporting the Activity Date of This ADC					[12]
Patients Enrolled	Eligible participants were &ge;18 years with metastatic non-squamous NSCLC progressing after platinum/immunotherapy, CEACAM5 expression &ge;2+ in &ge;50% tumor cells, measurable lesions, and ECOG 0-1. Exclusions included active brain metastases, other malignancies within 3 years, unresolved toxicities &ge;Grade 2, HIV/hepatitis, corneal disorders, prior docetaxel/CEACAM5-targeted therapy, corticosteroid contraindications, or hypersensitivity to study drugs.    Click to Show/Hide
Administration Dosage	Participants received tusamitamab ravtansine 100 milligrams per square meter (mg/m^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).
Related Clinical Trial
NCT Number	NCT04154956	Clinical Status	PHASE3
Clinical Description	Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors
Primary Endpoint	The study assessed Progression-free Survival (PFS) as the time from randomization to first documented disease progression (PD) or death per RECIST 1.1 criteria, with PD defined as 20% increase in target lesions (minimum 5mm absolute increase) or new lesions. Overall Survival (OS) was measured from randomization to death from any cause up to 189 weeks.    Click to Show/Hide
Other Endpoint	Objective Response Rate (ORR) measured the percentage of participants achieving complete (CR) or partial response (PR) per RECIST 1.1, where CR required lesion disappearance and PR required ≥30% decrease in target lesions. Time to Deterioration (TTD) in symptoms and functions was evaluated using EORTC QLQ-LC13/C30 scales, with deterioration defined as ≥10-point worsening. Safety endpoints included treatment-emergent adverse events (TEAEs/TESAEs), lab abnormalities, and Duration of Response (DOR) from first CR/PR to PD/death.    Click to Show/Hide
Experiment 16 Reporting the Activity Date of This ADC					[13]
Efficacy Data	Objective Response Rate (ORR)	40%	Low CEACAM5 expression (CEACAM5+; 299,300 sites/cell)
Patients Enrolled	Patients with advanced/metastatic nonsquamous non-small cell lung cancer (NSQ NSCLC) with CEACAM5 intensity of 2+ in 1% of tumor cells by immunohistochemistry.
Administration Dosage	IV Q3W at 150 or 170 mg/m2.
Related Clinical Trial
NCT Number	NCT04524689	Clinical Status	Phase 2
Clinical Description	Open-label, phase 2 study of tusamitamab ravtansine (SAR408701) combined with pembrolizumab and tusamitamab ravtansine (SAR408701) combined with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with CEACAM5 positive expression advanced/metastatic non-squamous non-small-cell lung cancer (nsq NSCLC).
Experiment 17 Reporting the Activity Date of This ADC					[14]
Efficacy Data	Objective Response Rate (ORR)	20.30, 7.10, 41.70, 8.10 %	Moderate CEACAM5 expression (CEACAM5++; 1,615,700 sites/cell)
Patients Enrolled	Enrolled 2 cohorts of patients with IHC CEACAM5 membrane expression at 2+ intensity: in 50% of tumor cells (high expressors, HEs, n = 64); and in 1% to <50% of tumor cells (moderate expressors, MEs, n = 28).
Administration Dosage	100 mg/m2 IV every 2 weeks.
Related Clinical Trial
NCT Number	NCT02187848	Clinical Status	Phase 1
Clinical Description	A first-in-human study for the evaluation of the safety, pharmacokinetics and antitumor activity of SAR408701 in patients with advanced solid tumors.
Primary Endpoint	The primary endpoint was the incidence of DLTs occurring during the first two cycles (4 weeks) of study drug administration. DLTs (reversible grade 3 microcystic keratopathy) occurred in three of eight patients treated with tusamitamab ravtansine 12.00 mg/m2 and in two of three patients treated with 15.00 mg/m2. The maximum tolerated dose was identified as 10.00 mg/m2.    Click to Show/Hide
Other Endpoint	Three patients (9.68%) had objective responses [all confirmed partial responses (PRs) with durations of 2.60, 6.10, and 4.00 months]; 11 patients (35.48%) had stable disease, and 13 patients (41.94%) had progressive disease. Objective responses were achieved in two of six patients (33.33%) at a DL of 10.0 mg/m2, and in one of nine patients (11.11%) at 12.0 mg/m2 with maximum reduction in RECIST target lesions of 32.30%-51.20%.    Click to Show/Hide
Experiment 18 Reporting the Activity Date of This ADC					[15]
Related Clinical Trial
NCT Number	NCT05703555	Clinical Status	Phase 2
Clinical Description	Intrusion: unraveling the intratumoral PK/PD relation for SAR408701.
Experiment 19 Reporting the Activity Date of This ADC					[16]
Related Clinical Trial
NCT Number	NCT04659603	Clinical Status	Phase 2
Clinical Description	Open-label, multi-cohort, phase 2 trial, evaluating the efficacy and safety of tusamitamab ravtansine (SAR408701) monotherapy and in combination in patients with CEACAM5-positive advanced solid tumors.
Experiment 20 Reporting the Activity Date of This ADC					[17]
Related Clinical Trial
NCT Number	NCT05071053	Clinical Status	Phase 2
Clinical Description	Open-label study of tusamitamab ravtansine (SAR408701) in combination with ramucirumab in participants previously treated for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma with CEACAM5-positive tumors.
Experiment 21 Reporting the Activity Date of This ADC					[18]
Related Clinical Trial
NCT Number	NCT05245071	Clinical Status	Phase 2
Clinical Description	Open-label, phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous non-small-cell lung cancer (nsq NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating CEA.
Experiment 22 Reporting the Activity Date of This ADC					[19]
Related Clinical Trial
NCT Number	NCT03324113	Clinical Status	Phase 1
Clinical Description	A phase 1 study to evaluate safety and pharmacokinetics of SAR408701 administered intravenously as monotherapy in japanese patients with advanced malignant solid tumors.
Experiment 23 Reporting the Activity Date of This ADC					[20]
Related Clinical Trial
NCT Number	NCT04154956	Clinical Status	Phase 1
Clinical Description	Randomized, open-label, phase 3 study of SAR408701 versus docetaxel in previously treated, metastatic nonsquamous, non-small-cell lung cancer patients with CEACAM5-positive tumors.
Experiment 24 Reporting the Activity Date of This ADC					[21]
Related Clinical Trial
NCT Number	NCT05429762	Clinical Status	Phase 1
Clinical Description	Open-label study evaluating the effect of tusamitamab ravtansine on the QTC interval in participants with metastatic solid tumors.

Experiment 1 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	0%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Experiment 2 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	6.40%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 3 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	27.10%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 4 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	32.90%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 5 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	41.50%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Experiment 6 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	55%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, twice a week with a single intravenous administration at 2.5 mg/kg for a total of 4 weeks.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 7 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	57.20%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Experiment 8 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	60.30%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Experiment 9 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	63.90%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 2.5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Experiment 10 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	66.20%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Experiment 11 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	69.70%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 12 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	69.80%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-0083)
Experiment 13 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	70.20%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 14 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	71.80%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Experiment 15 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	76.50%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, once a week with a single intravenous administration at 5 mg/kg for a total of 4 weeks.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 16 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	84.70%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Experiment 17 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	90.20%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Experiment 18 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	90.30%	Moderate CEACAM5 expression (CEACAM5++; IHC 2+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a lung adenocarcinoma patient with IHC 2+, twice a week with a single intravenous administration at 2.5 mg/kg for a total of 4 weeks.
In Vivo Model	Lung adenocarcinoma PDX model (PDX: LUN-NIC-014)
Experiment 19 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	91.40%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 20 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	92.40%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: STO-IND-0007)
Experiment 21 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	92.80%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Experiment 22 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	92.80%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Experiment 23 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	93.30%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a stomach adenocarcinoma patient with IHC 3+, with a single intravenous administration at 10 mg/kg.
In Vivo Model	Stomach adenocarcinoma PDX model (PDX: SA-STO-0014)
Experiment 24 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	93.50%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, with a single intravenous administration at 5 mg/kg.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 25 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	97%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, once a week with a single intravenous administration at 5 mg/kg for a total of 4 weeks.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)
Experiment 26 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	99.40%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, once a week with a single intravenous administration at 5 mg/kg for a total of 4 weeks.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 27 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	99.90%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, twice a week with a single intravenous administration at 2.5 mg/kg for a total of 4 weeks.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-002C/M)
Experiment 28 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Tumor Growth Inhibition value (TGI)	100%	High CEACAM5 expression (CEACAM5+++; IHC 3+)
Method Description	Tusamitamab ravtansine induces efficient tumor cell killing in PDX models of a colon adenocarcinoma patient with IHC 3+, twice a week with a single intravenous administration at 2.5 mg/kg for a total of 4 weeks.
In Vivo Model	Colon adenocarcinoma PDX model (PDX: CR-IGR-0034P)

Experiment 1 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.20±0.04 nM	Low CEACAM5 expression (CEACAM5+; 498,900 sites/cell)
Method Description	The inhibitory activity of SAR408377 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated incubated overnight.
In Vitro Model	Pancreatic ductal adenocarcinoma	HPAF-II cells		CVCL_0313
Experiment 2 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.38±0.07 nM
Method Description	The inhibitory activity of SAR408377 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated incubated overnight.
In Vitro Model	Pancreatic ductal adenocarcinoma	HPAF-II cells		CVCL_0313
Experiment 3 Reporting the Activity Date of This ADC					[22]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	1.08±0.17 nM
Method Description	The inhibitory activity of SAR408377 against cancer cell growth was evaluated in various human cancer cell lines in vitro. The cells were treated incubated overnight.
In Vitro Model	Gastric adenocarcinoma	MKN45 cells		CVCL_0434

Ref 1	Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study
Ref 2	Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens
Ref 3	Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors
Ref 4	Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Ref 5	Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab or Ramucirumab and Pembrolizumab in Pretreated Patients With NSQ NSCLC (CARMEN-LC04)
Ref 6	Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Tusamitamab Ravtansine (SAR408701) in Combination With Pembrolizumab and Platinum-based Chemotherapy With or Without Pemetrexed in Patients With NSQ NSCLC
Ref 7	Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
Ref 8	Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
Ref 9	Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
Ref 10	Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer
Ref 11	INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701
Ref 12	SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Ref 13	Preliminary results from a first-in-human study of ESG401, a trophoblast cell-surface antigen 2 (TROP2) antibody drug conjugate (ADC), in patients with locally advanced/metastatic solid tumors. J Clin Oncol. 2023 41:16_suppl, 1100-1100.
Ref 14	Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. Ann Oncol. 2022 Apr;33(4):416-425.
Ref 15	INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701, NCT05703555
Ref 16	Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors, NCT04659603
Ref 17	Open-label Study of Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Participants Previously Treated for Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma With CEACAM5-positive Tumors, NCT05071053
Ref 18	Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA, NCT05245071
Ref 19	A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors, NCT03324113
Ref 20	Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors, NCT04154956
Ref 21	Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors, NCT05429762
Ref 22	Preclinical Activity of SAR408701: A Novel Anti-CEACAM5-maytansinoid Antibody-drug Conjugate for the Treatment of CEACAM5-positive Epithelial Tumors. Clin Cancer Res. 2020 Dec 15;26(24):6589-6599.