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 )
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
- Pancreatic Cancer
- Pancreatic Cancer Metastatic
- PDAC
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Pancreatic Adenocarcinoma Metastatic
- Pancreatic Adenocarcinoma
- Pancreatic Adenosquamous Carcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Revolution Medicines, Inc.
- Enrolment target
- 670
- Started
- 22 May 2026
- Main results due
- 30 December 2028
- Study sites
- 13
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(13)
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Recruiting
Yale University
New Haven, Connecticut, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Piedmont Healthcare
Atlanta, Georgia, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Astera Cancer Care
East Brunswick, New Jersey, United States
Recruiting
Rutgers Cancer University
New Brunswick, New Jersey, United States
Recruiting
Columbia University Irving Medical Center
New York, New York, United States
Recruiting
Duke Cancer Center
Durham, North Carolina, United States
Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
Royal Marsden Hospital
London, United Kingdom
Recruiting
Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07621718. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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