Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
Part of paid clinical trials in San Francisco, California.
- Sponsor
- Repare Therapeutics
- Study ID
- NCT06560632
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Advanced Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- RP-3467 at assigned dose and schedule — DRUGEligible participants will be treated with escalating doses of RP-3467 monotherapy
- Olaparib 200-300 mg BID, daily — DRUGEligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib
Study Details
This is a multicenter, open-label Phase 1 trial to investigate the safety, PK, and pharmacodynamics of the Polθ inhibitor RP-3467 alone or in combination with the poly-ADP ribose polymerase inhibitor (PARPi) olaparib in adults with molecularly selected advanced solid tumors.
Key Dates
- Start date
- Sep 17, 2024
- Status verified
- Dec 2025
- Primary completion
- Oct 28, 2025
- Completion
- Oct 28, 2025
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: RP-3467 monotherapyEligible participants will be treated with escalating doses of RP-3467 monotherapy
- Experimental: Arm2: RP-3467 + Olaparib combinationEligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib
Primary Outcome Measure
The Number of Participants Who Experienced Dose-limiting Toxicities (DLT) During the Study Treatment [ Time Frame: Start of treatment to 30 days post last dose, up to 13 months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| # 1025, The University of California | San Francisco | California | 94158 | - |
| # 1011, The Washington University | St Louis | Missouri | 63130 | - |
| # 1004, Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | - |
| # 1008, Columbia University | New York | New York | 10032 | - |
| # 1001, The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | - |
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