RecruitingRecruiting
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 )
NCT07621718 · Revolution Medicines, Inc.
In plain English
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Official title
RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
About this study
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
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
Enrollment target: 670 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2030-04-22
Last updated: 2026-07-08
Interventions
Drug: ZoldonrasibDrug: PlaceboDrug: OxaliplatinDrug: Leucovorin (Calcium Folinate)Drug: 5-FluorouracilDrug: IrinotecanDrug: Gemcitabine (GEM)Drug: Nab-paclitaxel
Primary outcomes
- • Progression free survival (PFS) (Up to approximately 4 years)
- • Overall survival (OS) (Up to approximately 4 years)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines Study Director · contact · medinfo@revmed.com · 1-844-2-REVMED
All locations (4)
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Piedmont HealthcareRecruiting
Atlanta, Georgia, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States