Trials / Recruiting

RecruitingNCT07491445

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

Status: Recruiting
Phase: Phase 3
Study type: Interventional
Enrollment: 900 (estimated)

Sponsor: Revolution Medicines, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Detailed description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib monotherapy or daraxonrasib plus gemcitabine and nab-paclitaxel will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma. Patients will be randomized to one of three arms: daraxonrasib (Arm A), daraxonrasib + gemcitabine and nab-paclitaxel (Arm B), or gemcitabine and nab-paclitaxel (Arm C).

Conditions

Interventions

Type	Name	Description
DRUG	daraxonrasib	oral tablets
DRUG	gemcitabine	intravenous (IV) infusion
DRUG	nab-paclitaxel	IV infusion

Timeline

Start date: 2026-03-09
Primary completion: 2028-06-01
Completion: 2029-03-01
First posted: 2026-03-24
Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07491445. Inclusion in this directory is not an endorsement.