daraxonrasib

Drug

Drug Profile

Daraxonrasib (RMC-6236) is an oral direct multi-selective RAS(ON) inhibitor in late-stage oncology development for RAS-driven cancers, including pancreatic ductal adenocarcinoma, NSCLC, and colorectal cancer. It is being evaluated in multiple global Phase 3 registrational trials, including first-line metastatic PDAC settings. The therapy remains investigational and unapproved in the cited source.

Drug Class
Oral direct RAS(ON) multi-selective inhibitor
Approval Status
Investigational; currently in global Phase 3 registrational trials
Mechanism of Action
Suppresses RAS signaling by blocking interaction of wild-type and mutant RAS(ON) proteins with downstream effectors
Indications
  • \Metastatic pancreatic ductal adenocarcinoma (investigational, first-line and previously treated settings)\
  • \Non-small cell lung cancer (investigational)\
  • \Colorectal cancer (investigational)\

Related News

Recent Cancer Research Advances Span Treatments and Biomarkers

A phase one trial of RSO-021 achieved disease control in 67% of relapsed mesothelioma patients. Other advances include daraxonrasib for NRAS-driven melanoma, an aneuploidy biomarker for PARP inhibitor response in childhood cancers, and new research into a cancer target and cholangiocarcinoma treatment.

Revolution Medicines Begins Phase 3 Trial for Daraxonrasib in First-Line Pancreatic Cancer

Revolution Medicines has initiated patient treatment in the Phase 3 RASolute 303 trial testing daraxonrasib as first-line therapy for metastatic pancreatic cancer. The company also expects top-line data from its Phase 3 RASolute 302 trial in second-line pancreatic cancer in the first half of 2026. Both trials are evaluating the oral RAS(ON) inhibitor in pancreatic ductal adenocarcinoma, a highly lethal cancer with significant unmet medical need.

Related Clinical Trials

NCT ID Title Status Phase
NCT07756281

First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer

NOT_YET_RECRUITING PHASE1
NCT07573215

Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma

AVAILABLE
NCT07492680

A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

RECRUITING PHASE2
NCT07491445

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

RECRUITING PHASE3
NCT07397338

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

RECRUITING PHASE1/PHASE2
NCT07349537

Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

RECRUITING PHASE1
NCT07252232

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

RECRUITING PHASE3
NCT06881784

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

RECRUITING PHASE3
NCT06128551

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

RECRUITING PHASE1/PHASE2