Lung Cancer Clinical Trial
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Summary
Evaluate the safety and tolerability of RMC-6236 in adults with KRAS p.G12 mutant advanced solid tumors, KRAS p.G12C excluded.
Full Description
This is a Phase 1/1b, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing.
Received prior standard therapy appropriate for tumor type and stage
Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Exclusion Criteria:
Primary central nervous system (CNS) tumors
Active, untreated brain metastases
Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
Other inclusion/exclusion criteria may apply.
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There are 15 Locations for this study
Orange California, 92868, United States
Santa Monica California, 90404, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
New York New York, 10016, United States
New York New York, 10021, United States
New York New York, 10032, United States
Cincinnati Ohio, 45219, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78712, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
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