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Brief Title: Study of RP-3500 (Camonsertib) With Niraparib or Olaparib in Advanced Solid Tumors
Official Title: Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients With Molecularly Selected Cancers (ATTACC)
Study ID: NCT04972110
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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Participating Site #1018, Phoenix, Arizona, United States
Participating Site #1025, San Francisco, California, United States
Participating Site #1028, Aurora, Colorado, United States
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
Participating Site #1029, Eugene, Oregon, United States
Participating Site # 1001, Houston, Texas, United States
Participating Site # 1013, Salt Lake City, Utah, United States