Daraxonrasib alone or with gemcitabine and nab-paclitaxel for first-line metastatic pancreatic cancer
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
This trial will see if daraxonrasib, alone or with gemcitabine and nab-paclitaxel, helps people with newly diagnosed metastatic pancreatic cancer live longer or slow tumor growth compared with standard gemcitabine and nab-paclitaxel.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Revolution Medicines, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Henderson, Nevada and 1 other locations) |
| Trial ID | NCT07491445 on ClinicalTrials.gov |
What this trial studies
This is a global, randomized, open-label Phase 3 trial that randomizes patients with metastatic pancreatic adenocarcinoma to daraxonrasib alone, daraxonrasib plus gemcitabine and nab-paclitaxel, or standard gemcitabine and nab-paclitaxel. The primary goals are to compare progression-free survival and overall survival across the three arms. Eligible patients must have histologically confirmed metastatic PDAC, measurable disease, ECOG 0-1, documented RAS status, and no prior systemic therapy for metastatic disease. Treatment is given as first-line therapy and safety and tolerability will be monitored alongside efficacy outcomes.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed metastatic pancreatic adenocarcinoma, ECOG 0-1, measurable disease, documented RAS status, no prior metastatic systemic therapy, and able to take oral medication are ideal candidates.
Not a fit: Patients who have received prior systemic therapy for metastatic disease, have untreated CNS metastases, poor performance status, or cannot take oral medications are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, daraxonrasib alone or with chemotherapy could prolong progression-free and overall survival compared with current first-line chemotherapy and provide a targeted treatment option for some patients.
How similar studies have performed: Targeting KRAS has had success in other cancers (for example KRAS G12C inhibitors in lung cancer), but RAS(ON) inhibitors in pancreatic cancer are relatively new and clinical evidence in PDAC is limited though emerging.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Henderson, Nevada and 1 other locations
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States (Recruiting)
- Taylor Cancer Research Center — Maumee, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Revolution Medicines Study Director
- Email: medinfo@revmed.com
- Phone: 1-844-2-REVMED
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.