Recruiting

Phase 3

RAS(ON) InhibitorStudy 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 )

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07621718

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zoldonrasib

Placebo

Oxaliplatin

Leucovorin (Calcium Folinate)

5-Fluorouracil

Study Details

Brief 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.

Conditions

Pancreatic Cancer

Pancreatic Cancer Metastatic

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

Study ID

NCT07621718

Start date

May 22, 2026

Status verified date

Jul, 2026

Completion date

Apr 22, 2030

Anticipated

Primary completion date

Dec 30, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

Zoldonrasib

oral tablets

Placebo

oral tablets

Oxaliplatin

IV infusion

Leucovorin (Calcium Folinate)

IV infusion

5-Fluorouracil

IV infusion

Irinotecan

IV infusion

Gemcitabine (GEM)

IV infusion

Nab-paclitaxel

IV infusion

Primary outcome measure

Progression free survival (PFS) [ Time Frame: Up to approximately 4 years ]
Overall survival (OS) [ Time Frame: Up to approximately 4 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMED medinfo@revmed.com

Locations

The University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Zimmerman

520-626-8286 priscaz@arizona.edu

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Kim

813-745-3691 Cheyenne.Schneider@moffitt.org

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Mieri

404-425-1777 Takiyyah.Hamilton@piedmont.org

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Desgardin

773-834-7188 adesgard@bsd.uchicago.edu

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Apostol

410-502-7484 giclinicaltrials@jhmi.edu

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Yao

732-390-7750 eileen.peng@asterahealthcare.org

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Aug 21, 2026

Last verified

Jul, 2026

Keywords

Pancreatic Cancer
PDAC
Pancreatic Ductal Adenocarcinoma
RAS
KRAS
RAS Mutation
Pancreatic Cancer Metastatic
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenosquamous Carcinoma
Pancreatic Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-08-21.