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 )

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

Zoldonrasib (drug)
Placebo (drug)
Oxaliplatin (drug)
Leucovorin (Calcium Folinate) (drug)
5-Fluorouracil (drug)
Irinotecan (drug)

Sponsor: Revolution Medicines, Inc. · Participants: 670 · Started: May 22, 2026

Contact the study team

Revolution Medicines Study Director · Phone: 1-844-2-REVMED

Official record on ClinicalTrials.gov — NCT07621718

Locations in the U.S.

Arizona	The University of Arizona Cancer Center-North Campus, Tucson
Connecticut	Yale University, New Haven
Florida	Moffitt Cancer Center, Tampa
Georgia	Piedmont Healthcare, Atlanta
Illinois	University of Chicago Medical Center, Chicago
Maryland	Johns Hopkins University, Baltimore
Massachusetts	Dana Farber Cancer Institute, Boston
New Jersey	Astera Cancer Care, East Brunswick Rutgers Cancer University, New Brunswick
New York	Columbia University Irving Medical Center, New York
North Carolina	Duke Cancer Center, Durham
Texas	University of Texas MD Anderson Cancer Center, Houston

Conditions

Pancreatic Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.