Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Start Date
9/7/2023
Completion Date
4/30/2027
Summary
This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
Detailed Description
This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
RMC-9805
RMC-6236
Conditions
Locations
University of California, Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Smilow Cancer Hospital (Yale University)
New Haven, Connecticut 06511
United States
Florida Cancer Specialists
Sarasota, Florida 34232
United States
Lee Moffitt Cancer Center
Tampa, Florida 33612
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
NYU Langone
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
The Christ Hospital
Cincinnati, Ohio 45219
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas 75230
United States
University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United States
START
San Antonio, Texas 78229
United States
NEXT Oncology Virginia
Fairfax, Virginia 22031
United States