Ifinatamab deruxtecan

Phase 3Antibody–drug conjugate

Ifinatamab deruxtecan is one of 173 small molecule programs targeting Carcinoma, Non-Small-Cell Lung. It is currently in Phase 3.

Indications

Total Trials

Active Trials

172

Competitors

Pipeline

Status by Indication[3][1]

Indication

Carcinoma, Non-Small-Cell LungRecruiting

Castration Resistant Prostatic CancerRecruiting

Small Cell Lung CancerRecruiting

Recurrent or Metastatic Solid TumorsRecruiting

Esophageal Squamous Cell CarcinomaRecruiting

Malignant NeoplasmRecruiting

Advanced CancersActive, not recruiting

Malignant TumorsRecruiting

Carcinoma, Non-Small-Cell LungPhase 2

Recruiting

Castration Resistant Prostatic CancerPreclinical

Recruiting

Small Cell Lung CancerPhase 3

Recruiting

Recurrent or Metastatic Solid TumorsPreclinical

Recruiting

Esophageal Squamous Cell CarcinomaPhase 3

Recruiting

Malignant NeoplasmPreclinical

Recruiting

Advanced CancersPhase 2

Active, not recruiting

Malignant TumorsPhase 2

Recruiting

Competition

Competitive Landscape

154 competitors in Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 3

33 2

Imfinzi

AstraZeneca

Phase 3

30 3

Tecentriq

Roche

Phase 3

27 4

Camptosar

Pfizer

Phase 3

26 5

Keytruda

Merck & Co.

Phase 3

20 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

96 7

Avastin

Roche

Phase 3

16 8

Vepesid

Opdivo

Tarlatamab-Dznl

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

PreclinicalRecruiting

Recurrent or Metastatic Solid Tumors

NCT06330064

Q2 2029

PreclinicalRecruiting

Small Cell Lung Cancer

NCT06780137

Clinical

Trials by Indication[1]

Small Cell Lung Cancer4 trials

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

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

Show 1 more trial

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 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

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

5 more indications

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

SCLC1 trial

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

Available· Daiichi Sankyo logo

Daiichi Sankyo··NCT07535359

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

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

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

Q2 2029

Trials by Indication[1]

Small Cell Lung Cancer4 trials

Carcinoma, Non-Small-Cell Lung2 trials

Advanced Cancers1 trial

Malignant Tumors1 trial

Castration Resistant Prostatic Cancer1 trial

Prostate Cancer1 trial

Malignant Neoplasm1 trial

SCLC1 trial

Recurrent or Metastatic Solid Tumors1 trial

Esophageal Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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