NCT04497116

Study of RP-3500, Camonsertib, in Advanced Solid Tumors

Phase 1/2a Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-3500 Alone or in Combination With Talazoparib or Gemcitabine in Advanced Solid Tumors With ATR Inhibitor Sensitizing Mutations (TRESR Study)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Repare Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to define the maximum tolerated dose (MTD) and determine a recommended Phase 2 dose (RP2D) and schedule of orally-administered RP-3500 (camonsertib) alone or in combination with talazoparib, a PARP inhibitor, or Gemcitabine in patients with advanced solid tumors with ATR inhibitor-sensitizing mutations. This study will also evaluate the safety and tolerability of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine, examine both the pharmacokinetics (PK)and pharmacodynamics (PD)and investigate its anti-tumor activity in solid tumors.

Detailed description

This is a first-in-human, Phase 1/2a, multi-center, open-label, dose-escalation and expansion study to: * Evaluate the safety profile and MTD of RP-3500 (camonsertib) when administered orally, alone and in combination with talazoparib or gemcitabine, to establish the dose and schedule recommended for the Phase 2 * Characterize the PK profile of RP-3500 (camonsertib) alone or in combination with talazoparib or gemcitabine * Identify anti-tumor activity associated with RP-3500 (camonsertib) given alone or in combination with talazoparib or gemcitabine The initial cohorts will test RP-3500 (camonsertib) as monotherapy. Additional cohorts will enroll with RP-3500 (camonsertib) in combination with talazoparib or gemcitabine. After the RP2D and schedule is determined, expansion cohort(s) for RP-3500 (camonsertib) will be enrolled to study the anti-tumor effect, and further examine the safety and PK of RP-3500 (camonsertib) at the RP2D

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	RP-3500 (camonsertib)	Oral ATR inhibitor
DRUG	Talazoparib	Oral PARP inhibitor
DRUG	Gemcitabine Injection	Gemcitabine

Timeline

• Start date: 2020-07-22
• Primary completion: 2025-06-13
• Completion: 2025-06-13
• First posted: 2020-08-04
• Last updated: 2025-10-21
• Results posted: 2025-10-21

Locations

13 sites across 4 countries: United States, Canada, Denmark, United Kingdom

Regulatory

• FDA-regulated drug study