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Clinical Trials in the USA / NCT06445062
Recruiting Phase 1/2

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

NCT06445062 · tracked via the Priya Life Science USA tracker
Sponsor
Revolution Medicines, Inc
Phase
Phase 1/2
Started
2024-05-24
Last updated
2026-09-22

Condition(s) studied

Colorectal CancerCRCPancreatic Ductal AdenocarcinomaPDACGastrointestinal CancerMetastatic Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

RMC-6236 →mFOLFOX6 regimen →bevacizumab →mFOLFIRINOX regimen →cetuximab →gemcitabine →nab-paclitaxel →RMC-9805 →FOLFIRI regimen →

RMC-6236: Oral tablet

mFOLFOX6 regimen: IV infusion

bevacizumab: IV infusion

mFOLFIRINOX regimen: IV infusion

cetuximab: IV infusion

gemcitabine: IV infusion

nab-paclitaxel: IV infusion

RMC-9805: Oral Tablet

FOLFIRI regimen: IV infusion

Study summary

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents.

The current subprotocols include the following:

Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens

Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel

Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens

Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6

Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel

Subprotocol G: RMC-9805 + cetuximab + FOLFIRI

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: All Patients (unless otherwise noted): * ≥ 18 years of age * ECOG PS is 0 to 1 * Adequate organ function as outlined by the study * Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, C and G) * Presence of RAS G12D mutation (Subprotocol D, E, F, G) Exclusion Criteria: All Patients: * Primary central nervous system (CNS) tumors * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs * Major surgery within 28 days of first dose Other inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Adverse events (Subprotocols A-F) — Up to 3 years
    Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment.
  • Dose limiting toxicities (Subprotocols A-F) — 28 days
    Number of participants with dose limiting toxicities
  • Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)(Subprotocol G) — Up to 3 years

Trial sites (32)

FacilityCityRegionStatus
Ironwood Cancer and Research Centers Chandler Arizona Recruiting
Mayo Clinic Hospital Phoenix Arizona Recruiting
HonorHealth Research Institute Scottsdale Arizona Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
Cedars-Sinai Cancer at Cedars-Sinai Medical Center Los Angeles California Recruiting
UCLA Hematology/Oncology- Santa Monica Los Angeles California Recruiting
University of Colorado Hospital-Anschutz Cancer Pavilion Aurora Colorado Recruiting
Yale-New Haven Hospital-Yale Cancer Center New Haven Connecticut Recruiting
Mayo Clinic Cancer Center Jacksonville Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
The University of Kansas Clinical Research Center Westwood Kansas Recruiting
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Atlantic Health System Morristown New Jersey Recruiting
Northwell Health / RJ Zuckerberg Cancer Center Lake Success New York Recruiting
Columbia University Medical Center New York New York Recruiting
Memorial Sloan Kettering Cancer Center Main Campus New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology Dallas Irving Texas Recruiting
Huntsman Cancer Institute, University of Utah Salt Lake City Utah Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting

On this site

📄 Avastin (bevacizumab) drug profile →

More Revolution Medicines, Inc. trials in the USA

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Recruiting
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors Recruiting
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors Recruiting
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Active, not recruiting
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS Recruiting

Other trials for the same condition

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC) Active, not recruiting
PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting
A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer Recruiting
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101) Starting soon
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma 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 NCT06445062 on ClinicalTrials.gov ↗ ← All trials in the USA