Testing RP-3467 and Olaparib for Advanced Solid Tumors
Phase 1 Trial of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RP-3467 Alone and in Combination with Olaparib in Participants with Advanced Solid Tumors (POLAR Trial)
This study is testing a new drug called RP-3467, alone and with another drug called olaparib, to see if it can help adults with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Repare Therapeutics Industry-sponsored |
| Locations | 5 sites (San Francisco, California and 4 other locations) |
| Trial ID | NCT06560632 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial evaluates the safety and pharmacokinetics of the Polθ inhibitor RP-3467, both alone and in combination with the PARP inhibitor olaparib, in adults with advanced solid tumors that have not responded to previous treatments. The study is designed as a multicenter, open-label, dose-escalation approach to determine the maximum tolerated dose of RP-3467 and its pharmacodynamic effects. Participants will be closely monitored for safety and efficacy as the trial progresses.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors such as metastatic breast cancer, ovarian cancer, prostate cancer, or pancreatic adenocarcinoma that have progressed after prior therapies.
Not a fit: Patients with early-stage tumors or those who have not exhausted standard treatment options may not benefit from this trial.
Why it matters
Potential benefit: If successful, this trial could provide a new treatment option for patients with advanced solid tumors that currently have limited therapeutic alternatives.
How similar studies have performed: While this approach is novel in its specific combination, similar studies involving PARP inhibitors have shown promising results in treating advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. locally advanced or metastatic epithelial ovarian cancer (including fallopian tube or primary peritoneal), or 2. metastatic breast cancer, or 3. metastatic castration-resistant prostate cancer (mCRPC), or 4. 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 Criteria: * 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 this trial is running
San Francisco, California and 4 other locations
- Participating Site #1025 — San Francisco, California, United States (Recruiting)
- Participating Site #1011 — Saint Louis, Missouri, United States (Recruiting)
- Participating Site # 1008 — New York, New York, United States (Recruiting)
- Participating Site # 1004 — New York, New York, United States (Recruiting)
- Participating Site # 1001 — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Repare Clinical Representative
- Email: clininfo@reparerx.com
- Phone: 1 (857) 340-5402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.