Ifinatamab deruxtecan

Phase 3Antibody–drug conjugate

Ifinatamab deruxtecan is one of 210 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

209

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Prostate CancerRecruiting

Small Cell Lung CancerActive, not recruiting

Malignant NeoplasmNot yet recruiting

Carcinoma, Non-Small-Cell LungRecruiting

Castration Resistant Prostatic CancerRecruiting

Esophageal Squamous Cell CarcinomaPhase 3

Active, not recruiting

Metastatic Prostate CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Prostate CancerPhase 3

Recruiting

Small Cell Lung CancerPhase 1/Phase 2

Active, not recruiting

Malignant NeoplasmPreclinical

Not yet recruiting

Carcinoma, Non-Small-Cell LungPhase 2

Recruiting

Castration Resistant Prostatic CancerPreclinical

Recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Ifinatamab deruxtecan

Daiichi Sankyo

Phase 3

13 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

PORTRAZZA

Eli Lilly

Preclinical

8 5

Lenvima

Eisai

Preclinical

6 6

Imjudo

AstraZeneca

Preclinical

5 7

Vizimpro

Pfizer

Preclinical

4 8

Gilotrif

Boehringer Ingelheim

Preclinical

12 9

Ofev

Boehringer Ingelheim

Preclinical

7 10

Immunotherapy

Bristol-Myers Squibb

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

Phase 1/2Recruiting

Small Cell Lung Cancer

NCT06362252

Q1 2028

Phase 1/2Active, not recruiting

Advanced Cancers

NCT04471727

Q3 2028

Phase 2Recruiting

Recurrent or Metastatic Solid Tumors

NCT06330064

Q1 2029

Phase 3Recruiting

Small Cell Lung Cancer

NCT06203210

Clinical

Trials by Indication[1]

Small Cell Lung Cancer4 trials

A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT06203210·540 enrolled

A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1/2·NCT06362252·123 enrolled

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

Show 1 more trial

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

Carcinoma, Non-Small-Cell Lung2 trials

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

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

Malignant Tumors1 trial

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1/2·NCT04145622·250 enrolled

Recurrent or Metastatic Solid Tumors1 trial

A 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·Phase 2·NCT06330064·520 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Study of Ifinatamab Deruxtecan 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

4 more indications

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

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

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

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

Sources

References

[1]
ClinicalTrials.gov — 13 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 Cancer4 trials

Carcinoma, Non-Small-Cell Lung2 trials

Malignant Tumors1 trial

Recurrent or Metastatic Solid Tumors1 trial

Esophageal Squamous Cell Carcinoma1 trial

Advanced Cancers1 trial

Prostate Cancer1 trial

Malignant Neoplasm1 trial

Castration Resistant Prostatic Cancer1 trial

References

Drug Info

Quick Facts

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