Ifinatamab deruxtecan

Phase 3Antibody–drug conjugate

Ifinatamab deruxtecan is one of 132 small molecule programs targeting Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

131

Competitors

Pipeline

Status by Indication[3][1]

Indication

Small Cell Lung CancerRecruiting

Solid TumorActive, not recruiting

Malignant NeoplasmRecruiting

Malignant TumorsRecruiting

Advanced CancersActive, not recruiting

Castration Resistant Prostatic CancerRecruiting

Recurrent or Metastatic Solid TumorsRecruiting

Small Cell Lung CancerPhase 3

Recruiting

Solid TumorPreclinical

Active, not recruiting

Malignant NeoplasmPreclinical

Recruiting

Malignant TumorsPreclinical

Recruiting

Advanced CancersPhase 2

Active, not recruiting

Castration Resistant Prostatic CancerPreclinical

Recruiting

Recurrent or Metastatic Solid TumorsPreclinical

Recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Ifinatamab deruxtecan

Daiichi Sankyo

Phase 3

1 2

Fludara

Sanofi

Preclinical

2 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

3 5

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Navmi

SSummit Therapeutics

Preclinical

1 7

Carboplatin AUC-5

Merck & Co.

Preclinical

1 8

Tulmimetostat

Novartis

Preclinical

1 9

MHB036C

MMinghui Pharmaceutical (Hangzhou) Ltd

Preclinical

1 10

IN10018

IInxMed (Shanghai) Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Small Cell Lung Cancer

NCT05280470

Q1 2028

Phase 1/2Active, not recruiting

Advanced Cancers

NCT04471727

PreclinicalRecruiting

Lung Carcinoma

NCT06362252

Q3 2028

PreclinicalRecruiting

Recurrent or Metastatic Solid Tumors

NCT06330064

Q1 2029

PreclinicalRecruiting

Small Cell Lung Cancer

NCT06780137

Clinical

Trials by Indication[1]

Small Cell Lung Cancer3 trials

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 2·NCT05280470·187 enrolled

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

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06780137·327 enrolled

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06203210·540 enrolled

Carcinoma, Non-Small-Cell Lung2 trials

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)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT04165070·450 enrolled

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)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT06780085·96 enrolled

Advanced Cancers1 trial

A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT04471727·232 enrolled

Malignant Neoplasm1 trial

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07630974·134 enrolled

Prostate Cancer1 trial

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT06925737·1,440 enrolled

6 more indications

Esophageal Squamous Cell Carcinoma1 trial

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)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06644781·510 enrolled

Recurrent or Metastatic Solid Tumors1 trial

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)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT06330064·680 enrolled

Castration Resistant Prostatic Cancer1 trial

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)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT06863272·360 enrolled

SCLC1 trial

Medical Access Program for Ifinatamab Deruxtecan (I-DXd, DS-7300a)

No longer available· Daiichi Sankyo logo

Daiichi Sankyo··NCT07535359

Solid Tumor1 trial

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)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT04145622·247 enrolled

Lung Carcinoma1 trial

A Phase 1b/2, Multicenter, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody-Drug Conjugate (ADC), in Combination With Atezolizumab With or Without Carboplatin as First-line Induction or Maintenance, in Subjects With Extensive-stage Small Cell Lung Cancer (ES-SCLC) (IDeate-Lung03)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT06362252·123 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Ifinatamab deruxtecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ifinatamab deruxtecan compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ifinatamab deruxtecan. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Daiichi Sankyo

Ifinatamab deruxtecan

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q3 2028

Q1 2029

Trials by Indication[1]

Small Cell Lung Cancer3 trials

Carcinoma, Non-Small-Cell Lung2 trials

Advanced Cancers1 trial

Malignant Neoplasm1 trial

Prostate Cancer1 trial

Esophageal Squamous Cell Carcinoma1 trial

Recurrent or Metastatic Solid Tumors1 trial

Castration Resistant Prostatic Cancer1 trial

SCLC1 trial

Solid Tumor1 trial

Lung Carcinoma1 trial

References

Drug Info

Quick Facts

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