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 — DRUG
    Eligible participants will be treated with escalating doses of RP-3467 monotherapy
  • Olaparib 200-300 mg BID, daily — DRUG
    Eligible 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 monotherapy
    Eligible participants will be treated with escalating doses of RP-3467 monotherapy
  • Experimental: Arm2: RP-3467 + Olaparib combination
    Eligible 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)

FacilityCityStateZIPSite coordinators
# 1025, The University of CaliforniaSan FranciscoCalifornia94158-
# 1011, The Washington UniversitySt LouisMissouri63130-
# 1004, Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
# 1008, Columbia UniversityNew YorkNew York10032-
# 1001, The University of Texas M.D. Anderson Cancer CenterHoustonTexas77030-

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