Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
• Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
• ECOG performance status 0 or 1
• Adequate organ function
Locations
United States
California
University of California, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Connecticut
Smilow Cancer Hospital (Yale University)
RECRUITING
New Haven
Florida
Florida Cancer Specialists
RECRUITING
Sarasota
Lee Moffitt Cancer Center
RECRUITING
Tampa
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins University
RECRUITING
Baltimore
North Carolina
Duke Cancer Center
RECRUITING
Durham
Carolina BioOncology Institute
RECRUITING
Huntersville
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
NYU Langone
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
Sarah Cannon Research Institute at Mary Crowley
RECRUITING
Dallas
University of Texas, MD Anderson Cancer Center
RECRUITING
Houston
START
RECRUITING
San Antonio
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Contact Information
Primary
Revolution Medicines, Inc.
medinfo@RevMed.com
1-844-2-REVMED
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 604
Treatments
Experimental: RMC-9805 monotherapy arm
Dose exploration and dose expansion
Experimental: RMC-9805 plus RMC-6236 combination arm
Dose exploration and dose expansion
Related Therapeutic Areas
Sponsors
Leads: Revolution Medicines, Inc.