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

NCT06625320 · tracked via the Priya Life Science Germany tracker

Sponsor

Revolution Medicines, Inc

Phase

Phase 3

Started

2024-10-16

Last updated

2026-06-02

Condition(s) studied

Pancreatic CancerPDACPDAC - Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

RMC-6236 →Gemcitabine →nab-paclitaxel →Irinotecan →Liposomal irinotecan →5-fluorouracil →leucovorin →Oxaliplatin →

RMC-6236: Oral Tablets

Gemcitabine: intravenous (IV) infusion

nab-paclitaxel: IV infusion

Irinotecan: IV infusion

Liposomal irinotecan: IV infusion

5-fluorouracil: IV infusion

leucovorin: IV infusion

Oxaliplatin: IV infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 PDAC with metastatic disease. * Measurable disease per RECIST 1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation) * Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). * Able to take oral medications. Exclusion Criteria: * Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors). * History of or known central nervous system metastatic disease. * Any conditions that may affect the ability to take or absorb study treatment * Major surgery within 4 weeks prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures

Primary outcome measure(s)

Progression free survival (PFS) in the RAS G12-mutant population — Up to approximately 3 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by blinded independent central review (BICR)
Overall survival (OS) in the RAS G12-mutant population — Up to approximately 3 years
OS is defined as the time from randomization until death from any cause.

Trial sites (60)

Facility	City	Region
Banner MD Anderson Cancer Center	Gilbert	Arizona
Mayo Clinic Cancer Center - Phoenix	Phoenix	Arizona
City of Hope-Duarte	Duarte	California
Cedars-Sinai Medical Center	Los Angeles	California
UCLA	Los Angeles	California
UC San Diego Health Moores Cancer Center	San Diego	California
Mission Hall UCSF	San Francisco	California
Rocky Mountain Cancer	Aurora	Colorado
Mayo Clinic Cancer Center - Florida	Jacksonville	Florida
University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
Cancer Care Centers of Brevard Inc	Palm Bay	Florida
Moffitt Cancer Center	Tampa	Florida
The Queen's Medical Center	Honolulu	Hawaii
The University of Chicago Medical Center	Chicago	Illinois
Johns Hopkins	Baltimore	Maryland
Dana Farber Cancer Institute	Boston	Massachusetts
University of Michigan	Ann Arbor	Michigan
Karmanos Cancer Institute	Detroit	Michigan
Mayo Clinic Cancer Center - Rochester	Rochester	Minnesota
Washington University	St Louis	Missouri
Roswell Park Cancer Institute	Buffalo	New York
NYU Lagone Health	New York	New York
Memorial Sloan Kettering Cancer Center	New York	New York
Columbia University Medical Center	New York	New York
Duke University Medical Center	Durham	North Carolina
University of Cincinnati Medical Center	Cincinnati	Ohio
Stephenson Cancer Center	Oklahoma City	Oklahoma
Oregon Health and Science University	Portland	Oregon
Abramson Cancer Center Clinical Research Unit	Philadelphia	Pennsylvania
UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
Sarah Cannon Research Institute (Tennessee)	Nashville	Tennessee
Texas Oncology Sammons	Dallas	Texas
MD Anderson Cancer Center	Houston	Texas
Texas Oncology - Central South	Irving	Texas
Huntsman Cancer Institute	Salt Lake City	Utah
Virginia Cancer Specialists	Fairfax	Virginia
Fred Hutchinson Cancer Center	Seattle	Washington
Institut Paoli Calmettes	Marseille	France
Centre Eugene Marquis	Rennes	France
Hopital Paul Brousse	Villejuif	France

+ 20 more sites — see the full list on the official registry below.

More Revolution Medicines, Inc. trials in Germany

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

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC Recruiting

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

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

Other trials for the same condition

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours Recruiting

Mesopancreas Study in Pancreatic Cancer Starting soon

Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen Administered in Adult Patients With Metastatic or Locally Advanced PDAC Recruiting

ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06625320 on ClinicalTrials.gov ↗ ← All trials in Germany