NCT04972110

Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors

Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Repare Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of niraparib or olaparib in combination with RP-3500 (camonsertib), in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-3500 (camonsertib) in combination with niraparib or olaparib, examine pharmacokinetics (PK) and assess anti-tumor activity.

Detailed description

This is a first-in-human Phase 1b/2, multi-center, open-label, dose-escalation and expansion study to: * Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally in combination with niraparib or olaparib to establish the recommended Phase 2 dose and schedule. * Characterize the PK profile of RP-3500 (camonsertib) in combination with niraparib or olaparib * Assess anti-tumor activity associated with RP-3500 (camonsertib) in combination with niraparib or olaparib * Examine biomarker responses and establish a correlation with RP-3500 (camonsertib) treatment in combination with niraparib or olaparib. After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) in combination with niraparib or olaparib will be enrolled to study the anti-tumor effect, and further examine the safety, PK, and pharmacodynamic (PD). Sponsor decided to terminate study early therefore, the Phase 2 expansion was not conducted

Conditions

• Advanced Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	RP-3500 (camonsertib)	RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-11-13
• Completion: 2024-11-13
• First posted: 2021-07-22
• Last updated: 2025-10-30
• Results posted: 2025-10-30

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study