A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Revolution Medicines, Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
Interventions
- DrugRMC-6236
Oral Tablets
Locations (16)
- UC Irvine/Chao Family Comprehensive Cancer CenterOrange, California
- UCLASanta Monica, California
- Moffitt Cancer CenterTampa, Florida
- Johns Hopkins UniversityBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- Perlmutter Cancer Center at NYU Langone HealthNew York, New York