Lung Cancer Clinical Trial
Evaluation of RMC-6236 in Subjects With Advanced Solid Tumors Harboring Specific Mutations in KRAS
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, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult subjects with KRAS p.G12 mutant advanced solid tumors, p.G12C excluded, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated subject 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 KRAS p.G12A, KRAS p.G12D, KRAS p.G12R, KRAS p.G12S, or KRAS p.G12V mutations 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 to 1
Adequate organ function
Exclusion Criteria:
Tumor harboring the KRAS p.G12C mutation
Primary central nervous system (CNS) tumors
Known or suspected leptomeningeal or brain metastases or spinal cord compression
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 10 Locations for this study
Boston Massachusetts, 02215, United States
New York New York, 10016, United States
New York New York, 10021, United States
Cincinnati Ohio, 45219, United States
Nashville Tennessee, 37203, 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
How clear is this clinincal trial information?