ADC ID	DRG0NNKAQ
ADC Name	Ifinatamab deruxtecan
Synonyms	ifinatamab deruxtecan; DS-7300; DS-7300a; I-DXd; MK-2400    Click to Show/Hide
Organization	Daiichi Sankyo (Originator);Merck & Co. (Top20 MNC)
Drug Status	New Drug Application
Drug-to-Antibody Ratio	4
Structure
				2D MOL
Antibody Name	Ifinatamab					Antibody Info
Antigen Name	CD276 antigen (CD276); Hepatocyte growth factor receptor (MET)					Antigen Info
Payload Name	DXd					Payload Info
Therapeutic Target	DNA topoisomerase 1 (TOP1)					Target Info
Linker Name	Mc-Gly-Gly-Phe-Gly					Linker Info
Conjugate Type	Random Cysteines
Combination Type	deruxtecan

Dissocation Constant (Kd)	Binding Target	Description	Reference
117.6 ng/mL	Human 4lg B7-H3	Binding affinities of DS-7300a to B7-H3 orthologs	[1]
301.6 ng/mL	Human 2lg B7-H3	Binding affinities of DS-7300a to B7-H3 orthologs	[1]
127.6 ng/mL	Monkey 4lg B7-H3	Binding affinities of DS-7300a to B7-H3 orthologs	[1]
396.7 ng/mL	Monkey 2lg B7-H3	Binding affinities of DS-7300a to B7-H3 orthologs	[1]

Incubation Time	21days	Release	5.3%	Reference	[1]
Incubation Medium	human plasma
Description	The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation
Incubation Time	21days	Release	<5%	Reference	[1]
Incubation Medium	monkey plasma
Description	The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation
Incubation Time	21days	Release	<4%	Reference	[1]
Incubation Medium	Rat plasma
Description	The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation
Incubation Time	21days	Release	1.5%	Reference	[1]
Incubation Medium	mouse plasma
Description	The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation
Incubation Time	21days	Release	<5%	Reference	[1]
Incubation Medium	human serum
Description	We confirmed the in vitro stability of DS-7300a in human, cynomolgus monkey, rat, and mouse plasma. The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation ranged from 1.5% to 5.3% (Fig. 2E), indicating that DS-7300a is stable in plasma in vitro.    Click to Show/Hide
Incubation Time	21days	Release	<5%	Reference	[1]
Incubation Medium	cynomolgus monkey serum
Description	We confirmed the in vitro stability of DS-7300a in human, cynomolgus monkey, rat, and mouse plasma. The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation ranged from 1.5% to 5.3% (Fig. 2E), indicating that DS-7300a is stable in plasma in vitro.    Click to Show/Hide
Incubation Time	21days	Release	<5%	Reference	[1]
Incubation Medium	rat monkey serum
Description	We confirmed the in vitro stability of DS-7300a in human, cynomolgus monkey, rat, and mouse plasma. The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation ranged from 1.5% to 5.3% (Fig. 2E), indicating that DS-7300a is stable in plasma in vitro.    Click to Show/Hide
Incubation Time	21days	Release	<5%	Reference	[1]
Incubation Medium	mouse serum
Description	We confirmed the in vitro stability of DS-7300a in human, cynomolgus monkey, rat, and mouse plasma. The release rates of DXd from 100 ug/mL DS-7300a after a 21-day incubation ranged from 1.5% to 5.3% (Fig. 2E), indicating that DS-7300a is stable in plasma in vitro.    Click to Show/Hide

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	7.64	day*ug/mL	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Area Under the Concentration-Time Curve (AUC)	7.64±0.46	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	7.39±0.4	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	42±1.6	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	41.1±1.5	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	216±29	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	209±30	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140±160	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1120±140	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUC28d.	[1]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	7.64	day*ug/mL	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Volume of Distribution (Vd)	113	mL/kg	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Area Under the Concentration-Time Curve (AUC)	7.64±0.46	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	7.39±0.4	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUC28d.	[1]
Volume of Distribution (Vd)	113±2	mL/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	42±1.6	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	41.1±1.5	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUC28d.	[1]
Volume of Distribution (Vd)	94.1±8.9	mL/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	216±29	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	209±30	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUC28d.	[1]
Volume of Distribution (Vd)	73.1±11.1	mL/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	1140±160	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1120±140	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUC28d.	[1]
Volume of Distribution (Vd)	51.1±6.9	mL/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg.	[1]

Standard Type	Value	Units	Description	Reference
Area Under the Concentration-Time Curve (AUC)	7.64	day*ug/mL	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Area Under the Concentration-Time Curve (AUC)	7.64±0.46	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	7.39±0.4	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	42±1.6	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	41.1±1.5	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	216±29	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	209±30	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUC28d.	[1]
Area Under the Concentration-Time Curve (AUC)	1140±160	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1120±140	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUC28d.	[1]

Standard Type	Value	Units	Description	Reference
Elimination Half-Life (t1/2)	3.24	days	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Area Under the Concentration-Time Curve (AUC)	7.64	day*ug/mL	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Clearance (CL)	39.3	mL/day/kg	PK parameters of 0.3 mg/kg DS-7300a in plasma after single intravenousadministration to monkeys	[1]
Area Under the Concentration-Time Curve (AUC)	7.64±0.46	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	7.39±0.4	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg, AUC28d.	[1]
Clearance (CL)	39.3±2.4	mL/day/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg.	[1]
Elimination Half-Life (t1/2)	3.24±0.16	day	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 0.3 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	42±1.6	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	41.1±1.5	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg, AUC28d.	[1]
Clearance (CL)	23.8±0.9	mL/day/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg.	[1]
Elimination Half-Life (t1/2)	5.22±1.11	day	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 1 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	216±29	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	209±30	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg, AUC28d.	[1]
Clearance (CL)	14.1±2	mL/day/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg.	[1]
Elimination Half-Life (t1/2)	7.89±2.21	day	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 3 mg/kg.	[1]
Area Under the Concentration-Time Curve (AUC)	1140±160	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUCinf.	[1]
Area Under the Concentration-Time Curve (AUC)	1120±140	day*ug/mL	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg, AUC28d.	[1]
Clearance (CL)	8.89±1.19	mL/day/kg	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg.	[1]
Elimination Half-Life (t1/2)	4.81±1.53	day	PK parameters of DS-7300a in plasma after single intravenous administration to monkeys, 10 mg/kg.	[1]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
stable disease (SD)	NCT05280470	PHASE2	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)    Click to Show/Hide
progressive disease (PD)	NCT05280470	PHASE2	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)    Click to Show/Hide
Partial Response (PR)	NCT05280470	PHASE2	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)    Click to Show/Hide
Complete response (CR)	NCT05280470	PHASE2	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)    Click to Show/Hide
Undisclosed	NCT06780111	PHASE1|||PHASE2	A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E    Click to Show/Hide
Undisclosed	NCT06644781	PHASE3	A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Undisclosed	NCT06780098	PHASE2	KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)    Click to Show/Hide
Undisclosed	NCT04165070	PHASE1|||PHASE2	KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)    Click to Show/Hide
Undisclosed	NCT06780085	PHASE2	KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)    Click to Show/Hide
Undisclosed	NCT06780137	PHASE1|||PHASE2	A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
Undisclosed	NCT04471727	PHASE1|||PHASE2	A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).    Click to Show/Hide
Undisclosed	NCT06863272	PHASE1|||PHASE2	MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)    Click to Show/Hide
Undisclosed	NCT04145622	PHASE1|||PHASE2	Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)
Undisclosed	NCT06330064	PHASE2	A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Undisclosed	NCT05280470	Phase 2	A phase 2, multicenter, randomized, open-label study of DS-7300a, a B7-H3 antibody drug conjugate (ADC), in subjects with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Undisclosed	NCT04145622	Phase 1/2	Phase 1/2, two-part, multicenter first-in-human study of DS-7300a in subjects with advanced solid malignant tumors.

Standard Type	Value	Units	Animal Model (No. of PDX)
Tumor Growth Inhibition value (TGI)	≈ 100	%	Small cell lung cancer PDX model (PDX: CTG-2093)

Standard Type	Value	Units	Cell Line	Disease Model
Half Maximal Inhibitory Concentration (IC50)	0.36	nM	MFE-280 cells	Endometrial adenocarcinoma
Half Maximal Inhibitory Concentration (IC50)	0.37	nM	Rh41 cells	Alveolar rhabdomyosarcoma
Half Maximal Inhibitory Concentration (IC50)	0.55	nM	CCRF-CEM cells	T acute lymphoblastic leukemia
Undisclosed	.	.	CCRF-CEM cells	T acute lymphoblastic leukemia

Experiment 1 Reporting the Activity Date of This ADC					[2]
Efficacy Data	stable disease (SD)	49%
Patients Enrolled	Eligible participants are adults (≥18) with histologically confirmed ES-SCLC, measurable per RECIST 1.1, progressing after ≥1 platinum-based systemic therapy (≥2 cycles). Key exclusions: prior B7-H3/ADC (exatecan-based) therapy, active CNS metastases, uncontrolled cardiovascular/respiratory disease, ILD, unresolved toxicities (>Grade 1), active infections (HBV/HCV/HIV), or immunosuppressive steroid use (>10 mg/day prednisone equivalent). Live vaccines within 30 days or pregnancy also preclude enrollment.    Click to Show/Hide
Administration Dosage	I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W), 8/12 mg/kg.
Related Clinical Trial
NCT Number	NCT05280470	Clinical Status	PHASE2
Clinical Description	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) assessed by BICR (36 months), defined as confirmed CR (complete disappearance of lesions) or PR (≥30% reduction in lesion diameters) per RECIST 1.1. Safety is measured via treatment-emergent adverse events (TEAEs) occurring after treatment initiation.
Other Endpoint	Secondary endpoints include progression-free survival (PFS), duration of response (DoR), overall survival (OS), time to response (TTR), and disease control rate (DCR) assessed up to 36 months by BICR/investigator. Pharmacokinetic evaluations (Cmax, Tmax, Ctrough, AUC, T1/2) track I-DXd, anti-B7-H3 antibody, and MAAA-1181a levels; immunogenicity assesses treatment-emergent antidrug antibodies (ADAs).    Click to Show/Hide
Experiment 2 Reporting the Activity Date of This ADC					[2]
Efficacy Data	progressive disease (PD)	3%
Patients Enrolled	Eligible participants are adults (≥18) with histologically confirmed ES-SCLC, measurable per RECIST 1.1, progressing after ≥1 platinum-based systemic therapy (≥2 cycles). Key exclusions: prior B7-H3/ADC (exatecan-based) therapy, active CNS metastases, uncontrolled cardiovascular/respiratory disease, ILD, unresolved toxicities (>Grade 1), active infections (HBV/HCV/HIV), or immunosuppressive steroid use (>10 mg/day prednisone equivalent). Live vaccines within 30 days or pregnancy also preclude enrollment.    Click to Show/Hide
Administration Dosage	I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W), 8/12 mg/kg.
Related Clinical Trial
NCT Number	NCT05280470	Clinical Status	PHASE2
Clinical Description	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) assessed by BICR (36 months), defined as confirmed CR (complete disappearance of lesions) or PR (≥30% reduction in lesion diameters) per RECIST 1.1. Safety is measured via treatment-emergent adverse events (TEAEs) occurring after treatment initiation.
Other Endpoint	Secondary endpoints include progression-free survival (PFS), duration of response (DoR), overall survival (OS), time to response (TTR), and disease control rate (DCR) assessed up to 36 months by BICR/investigator. Pharmacokinetic evaluations (Cmax, Tmax, Ctrough, AUC, T1/2) track I-DXd, anti-B7-H3 antibody, and MAAA-1181a levels; immunogenicity assesses treatment-emergent antidrug antibodies (ADAs).    Click to Show/Hide
Experiment 3 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Partial Response (PR)	16%
Patients Enrolled	Eligible participants are adults (≥18) with histologically confirmed ES-SCLC, measurable per RECIST 1.1, progressing after ≥1 platinum-based systemic therapy (≥2 cycles). Key exclusions: prior B7-H3/ADC (exatecan-based) therapy, active CNS metastases, uncontrolled cardiovascular/respiratory disease, ILD, unresolved toxicities (>Grade 1), active infections (HBV/HCV/HIV), or immunosuppressive steroid use (>10 mg/day prednisone equivalent). Live vaccines within 30 days or pregnancy also preclude enrollment.    Click to Show/Hide
Administration Dosage	I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W), 8/12 mg/kg.
Related Clinical Trial
NCT Number	NCT05280470	Clinical Status	PHASE2
Clinical Description	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) assessed by BICR (36 months), defined as confirmed CR (complete disappearance of lesions) or PR (≥30% reduction in lesion diameters) per RECIST 1.1. Safety is measured via treatment-emergent adverse events (TEAEs) occurring after treatment initiation.
Other Endpoint	Secondary endpoints include progression-free survival (PFS), duration of response (DoR), overall survival (OS), time to response (TTR), and disease control rate (DCR) assessed up to 36 months by BICR/investigator. Pharmacokinetic evaluations (Cmax, Tmax, Ctrough, AUC, T1/2) track I-DXd, anti-B7-H3 antibody, and MAAA-1181a levels; immunogenicity assesses treatment-emergent antidrug antibodies (ADAs).    Click to Show/Hide
Experiment 4 Reporting the Activity Date of This ADC					[2]
Efficacy Data	Complete response (CR)	22%
Patients Enrolled	Eligible participants are adults (≥18) with histologically confirmed ES-SCLC, measurable per RECIST 1.1, progressing after ≥1 platinum-based systemic therapy (≥2 cycles). Key exclusions: prior B7-H3/ADC (exatecan-based) therapy, active CNS metastases, uncontrolled cardiovascular/respiratory disease, ILD, unresolved toxicities (>Grade 1), active infections (HBV/HCV/HIV), or immunosuppressive steroid use (>10 mg/day prednisone equivalent). Live vaccines within 30 days or pregnancy also preclude enrollment.    Click to Show/Hide
Administration Dosage	I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W), 8/12 mg/kg.
Related Clinical Trial
NCT Number	NCT05280470	Clinical Status	PHASE2
Clinical Description	A Phase 2, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung01)
Primary Endpoint	The primary endpoint is Objective Response Rate (ORR) assessed by BICR (36 months), defined as confirmed CR (complete disappearance of lesions) or PR (≥30% reduction in lesion diameters) per RECIST 1.1. Safety is measured via treatment-emergent adverse events (TEAEs) occurring after treatment initiation.
Other Endpoint	Secondary endpoints include progression-free survival (PFS), duration of response (DoR), overall survival (OS), time to response (TTR), and disease control rate (DCR) assessed up to 36 months by BICR/investigator. Pharmacokinetic evaluations (Cmax, Tmax, Ctrough, AUC, T1/2) track I-DXd, anti-B7-H3 antibody, and MAAA-1181a levels; immunogenicity assesses treatment-emergent antidrug antibodies (ADAs).    Click to Show/Hide
Experiment 5 Reporting the Activity Date of This ADC					[3]
Patients Enrolled	Eligibility requires locally advanced/metastatic esophageal SCC (1L setting), controlled HIV/HBV/HCV if applicable. Exclusions: prior systemic therapy for metastatic disease, high-risk tumor invasion (aorta/respiratory tract), uncontrolled effusions, corneal disease, or prior PD- (L)1/CTLA-4 treatment. HIV+ candidates with Kaposi's sarcoma are excluded.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06780111	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E
Primary Endpoint	Phase IB tracks Dose-Limiting Toxicities (DLTs) including Grade 3/4 hematologic/nonhematologic AEs (e.g., thrombocytopenia, febrile neutropenia) or treatment-related discontinuations (21-day window). Safety endpoints also cover AE incidence (28 months) and intervention discontinuation rates (25 months). Phase II measures ORR (73 months) per RECIST 1.1 via blinded central review.    Click to Show/Hide
Other Endpoint	Key efficacy outcomes include Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS) (all up to 73 months), and Disease Control Rate (DCR) with ≥6-month stability. Pharmacokinetics assess I-DXd parameters (Cmax/Tmax, AUC0-last/AUC-tau over 25 months), alongside antidrug antibody (ADA) development rates (73 months).
Experiment 6 Reporting the Activity Date of This ADC					[4]
Patients Enrolled	Eligible participants (≥18 years) require histologically confirmed unresectable/metastatic ESCC, progression post-platinum+ICI therapy (≤1 prior line), ≥1 measurable lesion (RECIST v1.1), and ECOG 0-1. Exclusions: prior B7-H3/topoisomerase inhibitors, adenosquamous subtype, high-risk tumor invasion (aorta/respiratory tract), active brain metastases, recent thromboembolic events (6 months), or clinically significant ILD/pulmonary disease. Chronic steroids (>10 mg/day prednisone-equivalent) are excluded except for inhalers/topicals.    Click to Show/Hide
Administration Dosage	Participants who are randomized to receive an intravenous infusion of I-DXd 12 mg/kg on Day 1 of every 21-day cycle (Q3W).
Related Clinical Trial
NCT Number	NCT06644781	Clinical Status	PHASE3
Clinical Description	A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Primary Endpoint	Primary efficacy endpoints include Overall Survival (OS) and Progression-Free Survival (PFS), both measured from randomization to death or disease progression (up to 54 months) by BICR per RECIST v1.1. Secondary outcomes are Objective Response Rate (ORR), Duration of Response (DoR), and Disease Control Rate (DCR). Patient-reported outcomes assess EORTC QLQ-C30/OES18 changes, while safety tracks TEAEs, AESIs, and ADA incidence over 54 months.    Click to Show/Hide
Other Endpoint	Pharmacokinetic analysis evaluates Tmax for I-DXd, anti-B7-H3 antibody, and MAAA-1181a through plasma sampling at specific timepoints (Cycle 1-4+ every 2 cycles, 21-day cycles). ADA development and treatment-emergent immunogenicity are monitored longitudinally (up to 54 months).
Experiment 7 Reporting the Activity Date of This ADC					[5]
Patients Enrolled	Eligible participants require histologically confirmed Stage IV squamous NSCLC with progression post anti-PD- (L)1 + platinum therapy. HIV/HBV/HCV-infected patients may enroll with controlled viral loads. Exclusions include small cell histology, uncontrolled cardiovascular/pulmonary disease, active CNS metastases, autoimmune/ILD conditions, dual HBV/HCV infection, transplant history, or recent major surgery complications.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06780098	Clinical Status	PHASE2
Clinical Description	KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)
Primary Endpoint	The primary efficacy measure is Objective Response Rate (ORR) evaluated per RECIST 1.1, with CR/PR assessments by both BICR and investigators over 84 months. Safety outcomes track AE incidence (84 months) and treatment discontinuations due to AEs (60 months).
Other Endpoint	Secondary endpoints include Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS) - all assessed up to 84 months. Disease progression criteria follow RECIST 1.1, requiring ≥20% increase (+5mm absolute) in target lesions or new lesions, with BICR evaluation for DOR and PFS.
Experiment 8 Reporting the Activity Date of This ADC					[6]
Patients Enrolled	Eligible participants require histologically confirmed Stage IV NSCLC (non-small cell) with no prior systemic treatment for metastatic disease. Key exclusions: small cell histology, active CNS metastases, uncontrolled autoimmune/infectious conditions, recent major surgery (<3 weeks), prior immunotherapy discontinuation due to severe irAEs, and active HBV/HCV infections unless properly controlled. Screening requirements include tumor tissue submission and completion within specified windows (35 days for Part A, 28 days for Part B).    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT04165070	Clinical Status	PHASE1|||PHASE2
Clinical Description	KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Primary Endpoint	The primary efficacy endpoint is Objective Response Rate (ORR) in Part A (24 months) per RECIST 1.1, with CR/PR assessments. Part B safety evaluates AE incidence (27 months), treatment discontinuations due to AEs, and dose-limiting toxicities (DLTs) by CTCAE 5.0 during the first 3 weeks.
Other Endpoint	Part A assesses Progression-Free Survival (PFS) using RECIST 1.1 (24 months) and AE-related outcomes. Part B includes ORR/DOR per BICR (24 months) along with pharmacokinetic parameters (Cmax/Ctrough) for investigational drugs (I-DXd, HER3-DXd, pembrolizumab) over 2 years.
Experiment 9 Reporting the Activity Date of This ADC					[7]
Patients Enrolled	Eligible participants include Stage IV nonsquamous NSCLC patients (EGFR/ALK/ROS1-negative) with RECIST 1.1-measurable disease, ECOG 0-1, and adequate organ function. Exclusions cover comorbidities like uncontrolled infections, recent radiotherapy, active malignancies, CNS metastases, autoimmune/ILDs, and prior transplant/HIV/Kaposi's sarcoma, ensuring protocol safety alignment.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06780085	Clinical Status	PHASE2
Clinical Description	KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC)
Primary Endpoint	The study evaluates Objective Response Rate (ORR) per RECIST 1.1 as the primary endpoint, defined by CR or PR. Adverse events (AEs), including discontinuation rates due to AEs, are monitored as secondary safety outcomes over specified timeframes.
Other Endpoint	Key efficacy measures include Duration of Response (DOR) and Progression-Free Survival (PFS) assessed per RECIST 1.1 via BICR, alongside Overall Survival (OS). DOR spans from initial response to PD or death, while PFS tracks time to PD/death post-randomization, and OS measures survival duration.
Experiment 10 Reporting the Activity Date of This ADC					[8]
Patients Enrolled	Eligible participants must have extensive-stage SCLC post-platinum therapy, archival/fresh tissue availability, and controlled HIV if applicable. Key exclusions cover active infections, uncontrolled cardiovascular/neurologic conditions, prior transplants, untreated brain metastases, recent radiotherapy, immunosuppressive therapy, and malignancies requiring active treatment within 3 years. Specific restrictions apply to Part 1, including recent anticancer therapies and corneal disease.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06780137	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
Primary Endpoint	The primary safety outcomes include the number of participants experiencing adverse events (AEs), dose-limiting toxicities (DLTs), and discontinuations due to AEs, assessed over 44 months. Efficacy measures include Objective Response Rate (ORR) per RECIST 1.1, evaluating CR or PR rates as determined by investigator assessments.
Other Endpoint	Secondary endpoints focus on Duration of Response (DOR) and Progression-Free Survival (PFS), defined per RECIST 1.1, alongside pharmacokinetic metrics (Cmax, Tmax, AUCt, t½, steady-state parameters) for gocatamig, I-DXd, anti-B7-H3 antibody, and DXd. Anti-drug antibody (ADA) incidence is also monitored for immunogenicity assessment.
Experiment 11 Reporting the Activity Date of This ADC					[9]
Patients Enrolled	Eligible participants must have DLL3-expressing malignancies: SCLC post-platinum therapy, relapsed/refractory NEPC, or other neuroendocrine tumors failing standard therapy. Key exclusions cover active CNS metastases, uncontrolled effusions, recent cardiovascular events (6 months), active hepatitis/HIV, transplants, immunosuppressive therapy (prednisone >10mg/day), interstitial lung disease, and investigational drug use within 3 weeks/5 half-lives. Autoimmune conditions and unresolved toxicities from prior treatments are prohibited.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT04471727	Clinical Status	PHASE1|||PHASE2
Clinical Description	A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN328 Monotherapy and HPN328 With Atezolizumab or Ifinatamab Deruxtecan (I-DXd) in Patients With Advanced Cancers Associated With Expression of Delta-like Canonical Notch Ligand 3 (DLL3).
Primary Endpoint	Safety endpoints include the percentage of participants experiencing adverse events (AEs) and discontinuing due to AEs, graded per NCI CTCAE v5.0 and ASTCT criteria, monitored for up to 4 years. Dose-limiting toxicities (DLTs) following HPN328 treatment (mono/combination) are tracked alongside comprehensive pharmacokinetic parameters (Cmax, Tmax, AUCt/inf, t½, CL, Vss, AC) for gocatamig, atezolizumab, and I-DXd in serum/plasma under single dose and steady state conditions.    Click to Show/Hide
Other Endpoint	Efficacy outcomes focus on tumor response using RECIST v1.1 (PCWG3-modified for NEPC), including ORR, EC-ORR (extra-cranial), BOR, PFS, EC-PFS, OS, DOR, and EC-DOR - all evaluated over 4 years. Immunogenicity is assessed via anti-drug antibody (ADA) incidence against gocatamig, atezolizumab, and I-DXd at designated timepoints. Response criteria incorporate target lesion measurements (≥30% decrease for PR, ≥20% increase for PD with 5mm threshold) and new lesion appearance.    Click to Show/Hide
Experiment 12 Reporting the Activity Date of This ADC					[10]
Patients Enrolled	Eligible participants must have metastatic prostate adenocarcinoma progressing on ADT with 1-2 prior ARPI therapies (PARPi allowed if indicated), stable ECOG 0-1, and bone therapy stability. Exclusions cover ILD, uncontrolled cardiovascular/metabolic conditions, prior mCRPC taxanes, active CNS metastases, steroids >10mg/day, recent radiotherapy, autoimmune/transplant history, and other malignancies requiring treatment within 3 years.    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06863272	Clinical Status	PHASE1|||PHASE2
Clinical Description	MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)
Primary Endpoint	Primary safety outcomes include DLTs (Grade 4 toxicities, significant Grade 3 events, treatment delays/discontinuations), AEs, and treatment discontinuations due to AEs in both efficacy (54 months) and safety lead-in phases (21 days), with PSA response rate additionally tracked in the efficacy phase. DLT criteria cover hematologic/nonhematologic toxicities, liver injuries, febrile neutropenia, and dose interruptions.    Click to Show/Hide
Other Endpoint	Key efficacy measures per PCWG-modified RECIST 1.1 include ORR (CR/PR), rPFS (radiological progression/death), OS, DOR (response maintenance), TFST (subsequent therapy initiation), time to PSA progression (≥25% increase + ≥2ng/mL threshold), and TTPP (pain progression per BPI-SF/AQA), all monitored for up to 54 months with Kaplan-Meier analyses.    Click to Show/Hide
Experiment 13 Reporting the Activity Date of This ADC					[11]
Patients Enrolled	Eligible participants must have ECOG 0-1, measurable lesions per RECIST 1.1 (excluding irradiated sites without progression), adequate organ function, and specified advanced/metastatic cancers (e.g., HNSCC, ESCC, NSCLC, SCLC, CRPC). Key exclusions include prior B7-H3/I-DXd treatment, ADC-related toxicities, multiple malignancies (exceptions apply), uncontrolled cardiovascular/pulmonary disease, active infections, and conditions compromising safety or study integrity per investigator assessment. ESCC Cohort 4 requires progression post-platinum/ICI with &le;1 prior line of systemic therapy.    Click to Show/Hide
Administration Dosage	Participants with advanced solid tumors who received I-DXd IV Q3W monotherapy during dose escalation phase. Enrollment to this phase is currently closed.
Related Clinical Trial
NCT Number	NCT04145622	Clinical Status	PHASE1|||PHASE2
Clinical Description	Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)
Primary Endpoint	The study assesses dose-limiting toxicities (DLTs) during Cycle 1 (Days 1-21) in dose escalation, monitors adverse events (AEs) through 8 treatment cycles (21 days each until progression), and evaluates the antitumor activity of ifinatamab deruxtecan (I-DXd) over the same 8-cycle period.
Other Endpoint	Pharmacokinetic analyses focus on AUClast, AUCtau, Cmax, Tmax, and Ctrough parameters during 8 treatment cycles (21-day cycles until progression), alongside anti-drug antibody (ADA) incidence tracking over the same timeframe to evaluate immunogenicity and drug exposure dynamics.
Experiment 14 Reporting the Activity Date of This ADC					[12]
Patients Enrolled	Eligibility requires ECOG 0-1, measurable lesions (RECIST v1.1), progression after standard therapy, and tumor-specific criteria (e.g., prior ICI/platinum for HNSCC; &le;3 lines for endometrial cancer; HER2-low status for breast cancer). Key exclusions: prior B7-H3/I-DXd treatment, ADC-related toxicities, untreated brain metastases, inadequate washout periods. Disease-specific mandates include biopsy availability (archival/tfresh), Child-Pugh A for HCC, and targeted therapy for actionable mutations.    Click to Show/Hide
Administration Dosage	Participants with recurrent or metastatic endometrial cancer who were previously treated with 1 or more systemic therapy who received an intravenous infusion of I-DXd 12 mg/kg.
Related Clinical Trial
NCT Number	NCT06330064	Clinical Status	PHASE2
Clinical Description	A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Primary Endpoint	The primary efficacy endpoint is Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 (complete/partial response confirmed) until progression/death (up to 57 months). Safety outcomes include dose-limiting toxicities (Grade ≥3 non-disease-related events in Cycle 1) and treatment-emergent adverse events (TEAEs) monitored from consent until 47 days post-treatment, graded via NCI-CTCAE v5.0 in the HCC cohort.    Click to Show/Hide
Other Endpoint	Secondary endpoints encompass incidence of TEAEs, serious AEs (SAEs), and adverse events of special interest (AESIs) through follow-up, alongside efficacy measures: Duration of Response (DoR), Progression-Free Survival (PFS), Disease Control Rate (DCR), and Overall Survival (OS). Pharmacokinetics (Cmax, Tmax, t1/2, Ctrough, AUC) and immunogenicity (ADA incidence) are evaluated via noncompartmental analysis during 21-day cycles up to 57 months.    Click to Show/Hide
Experiment 15 Reporting the Activity Date of This ADC					[13]
Related Clinical Trial
NCT Number	NCT05280470	Clinical Status	Phase 2
Clinical Description	A phase 2, multicenter, randomized, open-label study of DS-7300a, a B7-H3 antibody drug conjugate (ADC), in subjects with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Experiment 16 Reporting the Activity Date of This ADC					[14]
Related Clinical Trial
NCT Number	NCT04145622	Clinical Status	Phase 1/2
Clinical Description	Phase 1/2, two-part, multicenter first-in-human study of DS-7300a in subjects with advanced solid malignant tumors.

Experiment 1 Reporting the Activity Date of This ADC					[15]
Efficacy Data	Tumor Growth Inhibition value (TGI)	≈ 100%	High CD276 expression (CD276+++)
Method Description	PDX studies CTG-2093, CTG-0166, CTG-0820, and CTG-1061 studies were performed by Champions Oncology, Inc. Models were established by inoculating tumor fragments derived from patients with small cell lung cancer (SCLC), nonsmall cell lung cancer (NSCLC), head and neck cancer, and bladder cancer, respectively, which were maintained in host mice, subcutaneously into female Hsd: Athymic Nude-Foxn1nu mice.Group assignment was carried out when the tumor volume reached approximately 100 to 300 mm3. The tumor-bearing mice were treated with DS-7300a or relevant controls intravenously on days 0 and 14.    Click to Show/Hide
In Vivo Model	Small cell lung cancer PDX model (PDX: CTG-2093)

Experiment 1 Reporting the Activity Date of This ADC					[15]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.36 nM
Method Description	In vivo The target specificity and species cross-reactivity of DS-7304a were assessed. Its pharmacologic activities were evaluated in several human cancer cell lines in vitro and xenograft mouse models, including patient-derived xenograft (PDX) mouse models.
In Vitro Model	Endometrial adenocarcinoma	MFE-280 cells		CVCL_1405
Experiment 2 Reporting the Activity Date of This ADC					[15]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.37 nM
Method Description	In vivo The target specificity and species cross-reactivity of DS-7303a were assessed. Its pharmacologic activities were evaluated in several human cancer cell lines in vitro and xenograft mouse models, including patient-derived xenograft (PDX) mouse models.
In Vitro Model	Alveolar rhabdomyosarcoma	Rh41 cells		CVCL_2176
Experiment 3 Reporting the Activity Date of This ADC					[15]
Efficacy Data	Half Maximal Inhibitory Concentration (IC50)	0.55 nM
Method Description	In vivo The target specificity and species cross-reactivity of DS-7302a were assessed. Its pharmacologic activities were evaluated in several human cancer cell lines in vitro and xenograft mouse models, including patient-derived xenograft (PDX) mouse models.
In Vitro Model	T acute lymphoblastic leukemia	CCRF-CEM cells		CVCL_0207
Experiment 4 Reporting the Activity Date of This ADC					[15]
Method Description	In vivo The target specificity and species cross-reactivity of DS-7300a were assessed. Its pharmacologic activities were evaluated in several human cancer cell lines in vitro and xenograft mouse models, including patient-derived xenograft (PDX) mouse models.
In Vitro Model	T acute lymphoblastic leukemia	CCRF-CEM cells		CVCL_0207

Ref 1	DS-7300a, a DNA Topoisomerase I Inhibitor, DXd-Based Antibody-Drug Conjugate Targeting B7-H3, Exerts Potent Antitumor Activities in Preclinical Models
Ref 2	Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
Ref 3	Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
Ref 4	A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Ref 5	Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)
Ref 6	KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Ref 7	A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Ref 8	A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
Ref 9	A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)
Ref 10	A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
Ref 11	Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Ref 12	A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Ref 13	A Phase 2, Multicenter, Randomized, Open-label Study of DS-7300a, a B7-H3 Antibody Drug Conjugate (ADC), in Subjects With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC), NCT05280470
Ref 14	Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors, NCT04145622
Ref 15	DS-7300a, a DNA Topoisomerase I Inhibitor, DXd-Based Antibody-Drug Conjugate Targeting B7-H3, Exerts Potent Antitumor Activities in Preclinical Models. Mol Cancer Ther. 2022 Apr 1;21(4):635-646.