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Brief Title: Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
Official Title: Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)
Study ID: NCT05147272
Brief Summary: The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.
Detailed Description: Phase 1, multi-center, open-label, dose-escalation study to: * Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule * Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine * Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Participating site # 1018, Phoenix, Arizona, United States
Participating site # 1019, Los Angeles, California, United States
Participating site # 1017, Jacksonville, Florida, United States
Participating Site #1022, Tampa, Florida, United States
Participating Site # 1023, Grand Rapids, Michigan, United States
Participating site # 1016, Rochester, Minnesota, United States
Participating Site # 1008, New York, New York, United States
Participating Site # 1004, New York, New York, United States
Participating Site # 1010, Philadelphia, Pennsylvania, United States
Participating site # 2001, Toronto, Ontario, Canada
Participating site # 3003, London, , United Kingdom