Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
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. PDAC with wild-type RAS (expansion).
- Treatment naive or have 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05379985.
Locations matching your search criteria
United States
California
Los Angeles
Orange
Maryland
Baltimore
Massachusetts
Boston
New York
New York
Texas
Houston
Utah
Salt Lake City
This is a Phase 1/2, 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).
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationRevolution Medicines, Inc.
- Primary IDRMC-6236-001
- Secondary IDsNCI-2022-05170
- ClinicalTrials.gov IDNCT05379985