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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Revolution Medicines, Inc. · Participants: 1,130 · Started: May 24, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06445062

Locations in the U.S.

ArizonaIronwood Cancer and Research Centers, Chandler
Mayo Clinic Hospital, Phoenix
HonorHealth Research Institute, Scottsdale
CaliforniaUC San Diego Moores Cancer Center, La Jolla
Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles
UCLA Hematology/Oncology- Santa Monica, Los Angeles
ColoradoUniversity of Colorado Hospital-Anschutz Cancer Pavilion, Aurora
ConnecticutYale-New Haven Hospital-Yale Cancer Center, New Haven
FloridaMayo Clinic Cancer Center, Jacksonville
Moffitt Cancer Center, Tampa
KansasThe University of Kansas Clinical Research Center, Westwood
MarylandThe Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore
MassachusettsDana Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MinnesotaMayo Clinic, Rochester
NebraskaNebraska Cancer Specialists, Omaha
University of Nebraska Medical Center, Omaha
New JerseyAtlantic Health System, Morristown
New YorkNorthwell Health / RJ Zuckerberg Cancer Center, Lake Success
Columbia University Medical Center, New York
Memorial Sloan Kettering Cancer Center Main Campus, New York
North CarolinaDuke University Medical Center, Durham
OhioUniversity of Cincinnati Medical Center, Cincinnati
OklahomaStephenson Cancer Center, Oklahoma City
PennsylvaniaHospital of the University of Pennsylvania, Philadelphia
TennesseeSCRI Oncology Partners, Nashville
TexasBaylor College of Medicine, Houston
The University of Texas MD Anderson Cancer Center, Houston
NEXT Oncology Dallas, Irving
UtahHuntsman Cancer Institute, University of Utah, Salt Lake City
VirginiaVirginia Cancer Specialists, Fairfax
WashingtonFred Hutchinson Cancer Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.