NCT06560632

Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With 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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Repare Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 define the MTD or MAD for RP-3467 monotherapy and the RP2D for the combination * Characterize the PK profile of RP-3467 alone and in combination with olaparib

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RP-3467 at assigned dose and schedule	Eligible participants will be treated with escalating doses of RP-3467 monotherapy
DRUG	Olaparib 200-300 mg BID, daily	Eligible participants will be treated with escalating doses of RP-3467 in combination with Olaparib

Timeline

• Start date: 2024-09-17
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2024-08-19
• Last updated: 2026-01-16
• Results posted: 2026-01-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study