Status:
ACTIVE_NOT_RECRUITING
Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors
Lead Sponsor:
Repare Therapeutics
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This is a first-in-human Phase 1, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile of RP-3467 when administered orally alone and in combination with olaparib and to d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06560632
Start Date
September 17 2024
End Date
December 1 2028
Last Update
September 17 2025
Active Locations (5)
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1
# 1025, The University of California
San Francisco, California, United States, 94158
2
# 1011, The Washington University
St Louis, Missouri, United States, 63130
3
# 1008, Columbia University
New York, New York, United States, 10032
4
# 1004, Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065