A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01)
NCT06660654 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-10-14
Summary
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 \[ccRCC\]).
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumors
Interventions
- DRUG
-
Raludotatug deruxtecan
IV administration Q3W
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-06
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Belgium
- China
- Denmark
- France
- Italy
- Japan
- South Korea
- Spain
Study Locations
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