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 )
Purpose
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.
Conditions
- Pancreatic Cancer
- Pancreatic Cancer Metastatic
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Pancreatic Adenocarcinoma Metastatic
- Pancreatic Adenocarcinoma
- Pancreatic Adenosquamous Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Histologically or cytologically confirmed pancreatic adenocarcinoma. - Diagnosis of metastatic disease ≤ 6 weeks prior to screening. - Documented KRAS G12D mutation status. - Measurable disease per RECIST v1.1. - Adequate organ function (bone marrow, liver, kidney, coagulation). - Able to take oral medications.
Exclusion Criteria
- Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting. - Prior systemic RAS-targeted therapy any time prior to randomization. - Presence of other known driver mutations with approved targeted therapies - Active or known history of untreated central nervous system metastatic disease. - Any conditions that may affect the ability to take or absorb study drug. - Major surgery within 28 days prior to randomization. - Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Chemotherapy administration will be open label. This study is double-blind with respect to zoldonrasib versus placebo and treatment assignments will remain blinded to the Investigator, study center staff, patient, Sponsor, and study vendors.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: zoldonrasib + chemotherapy |
study drug in combination with Investigator choice chemotherapy (mFFX or GnP) |
|
|
Placebo Comparator Arm B: placebo + chemotherapy |
placebo in combination with Investigator choice chemotherapy (mFFX or GnP) |
|
Recruiting Locations
Piedmont Healthcare
Atlanta, Georgia 30318
Atlanta, Georgia 30318
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Johns Hopkins University
Baltimore, Maryland 21287
Baltimore, Maryland 21287
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
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).