Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Start Date
5/22/2026
Completion Date
4/22/2030
Summary
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
Detailed Description
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with Investigator choice of chemotherapy will improve progression-free survival or overall survival compared to placebo in combination with Investigator choice of chemotherapy when given to patients with previously untreated, 1L metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Choice of chemotherapy (mFFX or GnP) will be at the discretion of the Investigator. Patients will be randomized to one of two arms: zoldonrasib + Investigator choice of chemotherapy (Arm A) or placebo + Investigator choice of chemotherapy (Arm B).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Zoldonrasib
Placebo
Oxaliplatin
Leucovorin (Calcium Folinate)
5-Fluorouracil
Irinotecan
Gemcitabine (GEM)
Nab-paclitaxel
Conditions
Locations
Mayo Clinic Arizona
Phoenix, Arizona 85054
United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
Yale University
New Haven, Connecticut 06511
United States
University of Florida
Gainesville, Florida 32610
United States
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Piedmont Cancer Institute
Atlanta, Georgia 30318
United States
Piedmont Healthcare
Atlanta, Georgia 30318
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Astera Cancer Care
East Brunswick, New Jersey 08816
United States
Rutgers Cancer University
New Brunswick, New Jersey 08901
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Duke Cancer Center
Durham, North Carolina 27710
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Royal Marsden Hospital
London, SW3 6JJ
United Kingdom