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Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

NCT05379985 · Revolution Medicines, Inc.
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Official title
A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
About this study
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).
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. 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.
Study design
Enrollment target: 754 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-05-31
Estimated completion: 2027-07-26
Last updated: 2025-11-12
Interventions
Drug: RMC-6236
Primary outcomes
  • Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs (up to 2.5 years)
  • Number of Participants with Dose-Limiting Toxicity (DLT) (21 days)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines, Inc. · contact · medinfo@revmed.com · 1-844-273-8633
InvestigatorRevolution Medicines, Inc. · study_director, Revolution Medicines, Inc.
All locations (16)
UC Irvine/Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
UCLARecruiting
Santa Monica, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Columbia UniversityRecruiting
New York, New York, United States
Christ Hospital Cancer CenterRecruiting
Cincinnati, Ohio, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
University of Texas at AustinRecruiting
Austin, Texas, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Next OncologyRecruiting
San Antonio, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Next Oncology VirginiaRecruiting
Fairfax, Virginia, United States
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS · TrialPath