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A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)

StatusActive, Not Recruiting
PhasePhase 2
Started2025-01-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 27 months later Sep 30, 2027 → Dec 30, 2029
See other at-risk trials from Daiichi Sankyo

Amendment history

2026-09-25
Enrollment increased: 200 → 335 participants
Primary completion pushed: 2027-09-30 → 2029-12-30
Completion pushed: 2027-09-30 → 2029-12-30
2026-05-27
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 48 of 48 sites
2025-10-09
Study Status, Contacts/Locations v8
Study sites42→48
2025-09-05
Study Status, Contacts/Locations v7
Study sites38→42
2025-08-07
Study Status, Contacts/Locations v6
Study sites14→38
Show 5 earlier versions
2025-06-02
Study Status, Contacts/Locations v5
Study sites10→14
2025-05-13
Study Status, Contacts/Locations v4
Study sites8→10
2025-03-31
Study Status, Contacts/Locations v3
Study sites6→8
2025-03-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-31→confirmed 2025-01-06
Study sites3→6
2025-01-10
Study Status, Contacts/Locations v1
Study sites1→3
2024-10-25
Original filing
Daiichi Sankyo
69 trials monitored
See 8 trials at risk
This pan-tumor trial is designed as a signal-seeking trial to assess efficacy and safety of raludotatug deruxtecan (R-DXd) monotherapy in locally advanced or metastatic solid tumors with various cadherin-6 (CDH6) expression levels, including gynecological cancers (endometrial cancer, cervical cancer, and non-high-grade serous ovarian cancer) and genitourinary cancers (urothelial cancer and clear cell renal cell carcinoma \[ccRCC\]).
Trial Details
NCT Number NCT06660654
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced Solid Tumor, Metastatic Solid Tumors
Enrollment 335 participants
Start Date 2025-01-06
Primary Completion 2029-12-30 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-24