Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors
brief 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
official title
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)