RecruitingPhase 3NCT07621718

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


Sponsor

Revolution Medicines, Inc.

Enrollment

670 participants

Start Date

May 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-Fluorouracil, a drug called Gemcitabine (GEM), and others for people with pdac, pdac - pancreatic ductal adenocarcinoma, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZoldonrasib

oral tablets

DRUGPlacebo

oral tablets

DRUGOxaliplatin

IV infusion

DRUGLeucovorin (Calcium Folinate)

IV infusion

DRUG5-Fluorouracil

IV infusion

DRUGIrinotecan

IV infusion

DRUGGemcitabine (GEM)

IV infusion

DRUGNab-paclitaxel

IV infusion


Locations(4)

Moffitt Cancer Center

Tampa, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT07621718


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