Raludotatug Deruxtecan
Sponsors
Merck Sharp & Dohme LLC, Daiichi Sankyo Inc., Daiichi Sankyo
Conditions
Advanced Solid TumorAdvanced/metastatic solid tumors including gynecological
cancers (endometrial cancerCarcinoma, Non-Small-Cell LungGastrointestinal CancersMetastatic Solid TumorsNon-small Cell Lung CancerOvarian Cancer RecurrentParticipants with extensive-stage small cell lung cancer
Phase 1
A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)
Active, not recruitingCTIS2023-507687-38-00
Start: 2021-08-23Target: 59Updated: 2026-01-09
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
RecruitingNCT06843447
Start: 2025-04-15End: 2029-03-27Target: 280Updated: 2026-03-27
Phase 2
A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
RecruitingCTIS2023-507914-28-00
Start: 2024-06-19Target: 293Updated: 2025-10-27
A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
RecruitingNCT06660654
Start: 2025-01-06End: 2027-09-30Target: 200Updated: 2025-10-14
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
REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants with Advanced/Metastatic Solid Tumors
RecruitingCTIS2024-513307-13-00
Start: 2025-05-26Target: 73Updated: 2026-01-08
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
RecruitingCTIS2024-517416-30-00
Start: 2025-03-31Target: 54Updated: 2025-12-12
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