NCT07491445PHASE3RECRUITING3 endpoints open for prediction

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

Sponsor: Revolution Medicines, Inc.

Open for Predictions · 3 endpoints

NCT07491445Hazard Ratio for Progression-Free Survival (PFS)Primary

A Hazard Ratio below 1.0 favours the treatment arm. HR 0.65 means a 35% reduction in the risk of progression or death.

Prediction range: 0.3 – 1.1 Hazard Ratio

NCT07491445Hazard Ratio for Overall Survival (OS)Primary

A Hazard Ratio below 1.0 favours the treatment arm. HR 0.75 means a 25% reduction in the risk of death.

Prediction range: 0.4 – 1.2 Hazard Ratio

NCT07491445Objective Response Rate (ORR %)

The percentage of patients with confirmed complete or partial response per RECIST 1.1. Higher is better.

Prediction range: 0 – 100 %

Key Facts

Study type

INTERVENTIONAL

Conditions

Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

daraxonrasib, gemcitabine, nab-paclitaxel

Enrollment

900 participants

Primary completion

Jun 2028

Study completion

Mar 2029

First posted

Mar 2026

Last updated

May 2026

Primary Endpoints (CT.gov)

Progression free survival (PFS)

Time frame: Up to approximately 2 years

Overall survival (OS)

Time frame: Up to approximately 2 years

Secondary Endpoints

Objective response rate (ORR)

Duration of response (DOR)

Concentration of daraxonrasib in Arm A and B

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 informed consent. * Documented RAS mutation status, either mutant or wild-type. * 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 metastatic setting or prior RAS-targeted therapy in any treatment setting. * 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.

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov

Related Program

Daraxonrasib

Revolution Medicines, Inc.

View program page →