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Poly-ADP Ribose Polymerase Inhibitor

Arm 1: RP-3467 monotherapy for Solid Tumors (POLAR Trial)

Phase 1
Waitlist Available
Research Sponsored by Repare Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

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 (PARPi) olaparib in adults with molecularly selected advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have specific molecular characteristics. Participants must meet certain health standards and not be receiving other cancer treatments.
What is being tested?
The study tests the safety and effects of RP-3467, a new potential cancer drug, both alone and combined with Olaparib, an existing treatment. It's to see how these drugs work in patients with advanced tumors.
What are the potential side effects?
Possible side effects may include nausea, fatigue, blood count changes, or allergic reactions related to RP-3467 or Olaparib. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To assess the safety and tolerability of RP-3467 alone and in combination with olaparib
To define a preliminary recommended Phase 2 dose (RP2D) of RP-3467 in combination with olaparib
Secondary study objectives
To assess PK parameters of RP-3467 alone or in combination with olaparib with calculation of maximum observed plasma concentration (Cmax)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm2: RP-3467 + Olaparib combinationExperimental Treatment2 Interventions
Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib
Group II: Arm 1: RP-3467 monotherapyExperimental Treatment1 Intervention
Eligible participants will be treated with escalating doses of RP-3467 monotherapy

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Who is running the clinical trial?

Repare TherapeuticsLead Sponsor
9 Previous Clinical Trials
1,266 Total Patients Enrolled
~35 spots leftby Oct 2026
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