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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
RP-3500 (camonsertib, ATR inhibitor) in combination with niraparib or olaparib (PARP inhibitors)
Participating Site #1018
Phoenix, Arizona, United States
Participating Site #1025
San Francisco, California, United States
Participating Site #1028
Aurora, Colorado, United States
Determine the Safety and Tolerability of Niraparib or Olaparib in Combination With RP-3500 in Patients With Molecularly Selected Solid Tumors
Treatment Related Treatment-Emergent Adverse Events (TRAE) with ≥3 CTCAE Grade
Time frame: Start of treatment to 30 days post last dose, up to 23.7 months
Define the Recommended Phase 2 Dose (RP2D) of RP-3500 in Combination With Niraparib or Olaparib in Patients With Molecularly Selected Solid Tumors
Frequency of DLTs during the DLT observation period
Time frame: During 21 days (one cycle) from the initiation of the study treatment
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Participating Site #1012
New Haven, Connecticut, United States
Participating Site #1017
Jacksonville, Florida, United States
Participating Site #1009
Baltimore, Maryland, United States
Participating Site #1015
Ann Arbor, Michigan, United States
Participating Site # 1016
Rochester, Minnesota, United States
Participating Site #1026
New York, New York, United States
Participating Site # 1008
New York, New York, United States
...and 3 more locations