Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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 facts

Study ID

NCT06560632

Run by

Repare Therapeutics

People needed

26

Starts

2024-09-17

Expected to finish

2025-10-28

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants ≥18 years of age at the time of signing the informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participant must have one of the following that has progressed or was non-responsive to prior systemic therapy and for which no standard or available known therapeutic option exists:
• locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or
• metastatic breast cancer, or
• metastatic castration-resistant prostate cancer (mCRPC), or
• pancreatic adenocarcinoma
• Measurable disease per RECIST v1.1 (exceptions for participants with non-measurable but evaluable disease [per RECIST and or PSA/CA-125])
• Next generation sequencing (NGS) report demonstrating eligible tumor biomarker
• Provision of archival tumor tissue, or if adequate archival tumor tissue is not available, provision of a fresh biopsy if there is a lesion that can be safely biopsied
• Acceptable organ function at Screening
• Acceptable hematologic function at Screening
• Life expectancy ≥12 weeks after the start of the treatment according to the Investigator's judgment

You may not qualify if…

• History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.
• Uncontrolled, symptomatic brain metastases.
• Presence of other known active invasive cancers
• History of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) diagnosis
• Prior therapy with a Polθ inhibitor other than RP-3467

Where it is running

• # 1025, The University of California — San Francisco, California, United States
• # 1011, The Washington University — St Louis, Missouri, United States
• # 1008, Columbia University — New York, New York, United States
• # 1004, Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• # 1001, The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.