Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
Start Date
1/8/2026
Completion Date
10/1/2028
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
Detailed Description
This is an open-label, multicenter, Phase 1/1b study of RMC-5127 in adults with advanced KRAS G12V-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: RMC-5127 monotherapy arm, RMC-5127 plus daraxonrasib combination arm, and RMC-5127 plus cetuximab combination arm. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Both parts of the monotherapy arm may include Food Effect Cohorts.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
RMC-5127
daraxonrasib
cetuximab
Conditions
Locations
Yale Cancer Center
New Haven, Connecticut 06511
United States
Johns Hopkins
Baltimore, Maryland 21231
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
START Midwest
Grand Rapids, Michigan 49546
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
NEXT - Dallas
Dallas, Texas 75039
United States
NEXT
San Antonio, Texas 78229
United States
START - San Antonio
San Antonio, Texas 78229
United States
NEXT - Virginia
Fairfax, Virginia 22031
United States