Ifinatamab deruxtecan
Sponsors
Daiichi Sankyo Inc., Merck Sharp & Dohme LLC, Daiichi Sankyo
Conditions
Carcinoma, Non-Small-Cell LungCastration-Resistant Prostatic CancerEsophageal Squamous Cell CarcinomaEsophageal Squamous Cell Carcinoma (ESCC)Esophageal squamous cell carcinomaExtensive Stage-small Cell Lung CancerExtensive-stage Small Cell Lung Cancer (ES-SCLC)Metastasis
Phase 1
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)
RecruitingNCT06362252
Start: 2024-07-22End: 2026-12-30Target: 123Updated: 2026-02-06
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).
RecruitingCTIS2023-509629-36-00
Start: 2025-10-29Target: 23Updated: 2025-09-05
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
RecruitingCTIS2023-509632-26-00
Start: 2025-02-11Target: 266Updated: 2025-11-14
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)
RecruitingNCT06863272
Start: 2025-07-03End: 2031-04-01Target: 360Updated: 2026-04-02
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
RecruitingCTIS2024-517926-25-00
Start: 2025-03-12Target: 40Updated: 2025-11-21
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 Untreated Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E
RecruitingCTIS2024-514273-22-00
Start: 2025-09-02Target: 35Updated: 2025-09-05
Phase 2
A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
RecruitingNCT06330064
Start: 2024-04-10End: 2028-07-25Target: 520Updated: 2026-02-12
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)
Active, not recruitingCTIS2024-512368-79-00
Start: 2022-10-10Target: 49Updated: 2025-09-09
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
RecruitingNCT06780085
Start: 2025-05-13End: 2032-03-12Target: 96Updated: 2026-03-23
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)
RecruitingCTIS2024-518839-11-00
Start: 2025-08-25Target: 66Updated: 2026-01-19
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)
RecruitingCTIS2024-518761-10-00
Start: 2025-08-25Target: 41Updated: 2025-12-10
Phase 3
A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
RecruitingNCT06203210
Start: 2024-05-21End: 2029-02-22Target: 540Updated: 2026-03-02
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)
Active, not recruitingCTIS2023-509628-16-00
Start: 2024-10-21Target: 272Updated: 2025-11-03
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
RecruitingNCT06644781
Start: 2025-03-27End: 2029-11-01Target: 510Updated: 2026-01-12
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
RecruitingNCT06925737
Start: 2025-05-13End: 2031-01-06Target: 1440Updated: 2026-04-02
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate Prostate01)
RecruitingCTIS2024-517423-40-00
Start: 2025-06-23Target: 508Updated: 2025-12-05
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)
RecruitingCTIS2023-509630-19-00
Start: 2025-07-31Target: 198Updated: 2025-12-04