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RECRUITING
NCT07621718
PHASE3

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 )

Sponsor: Revolution Medicines, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

670

Start Date

2026-05-22

Completion Date

2030-04-22

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Zoldonrasib

oral tablets

DRUG

Placebo

oral tablets

DRUG

Oxaliplatin

IV infusion

DRUG

Leucovorin (Calcium Folinate)

IV infusion

DRUG

5-Fluorouracil

IV infusion

DRUG

Irinotecan

IV infusion

DRUG

Gemcitabine (GEM)

IV infusion

DRUG

Nab-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