NCT06625320

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• 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 a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Detailed description

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen. Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Conditions

• Pancreatic Cancer
• PDAC
• PDAC - Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	RMC-6236	Oral Tablets
DRUG	Gemcitabine	intravenous (IV) infusion
DRUG	nab-paclitaxel	IV infusion
DRUG	Irinotecan	IV infusion
DRUG	Liposomal irinotecan	IV infusion
DRUG	5-fluorouracil	IV infusion
DRUG	leucovorin	IV infusion
DRUG	Oxaliplatin	IV infusion

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-06-01
• Completion: 2027-12-01
• First posted: 2024-10-03
• Last updated: 2025-12-12

Locations

60 sites across 7 countries: United States, France, Germany, Italy, Japan, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study