Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Sponsor: Revolution Medicines, Inc.
ClinicalTrials ID:NCT05379985
This Phase 1/2 open-label study assesses the safety, tolerability, and pharmacokinetics of RMC-6236, an oral RAS-MULTI(ON) inhibitor, in adults with advanced solid tumors with specific RAS mutations. Eligible participants must have confirmed mutations, be treatment-naive or previously treated, have an ECOG status of 0-1, and adequate organ function.
Patient Parameters
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Program Overview
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
Description
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC Irvine/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| UCLA | 90404 | Santa Monica | California |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Johns Hopkins University | 21287 | Baltimore | Maryland |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Perlmutter Cancer Center at NYU Langone Health | 10016 | New York | New York |
| Memorial Sloan-Kettering Cancer Center | 10021 | New York | New York |
| Columbia University | 10032 | New York | New York |
| Christ Hospital Cancer Center | 45219 | Cincinnati | Ohio |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
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