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

Description

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

Conditions

Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC, Gastrointestinal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth Research Institute, Scottsdale, Arizona, United States, 85258

Los Angeles

UCLA Hematology/Oncology- Santa Monica, Los Angeles, California, United States, 90404

Aurora

University of Colorado Hospital-Anschutz Cancer Pavilion, Aurora, Colorado, United States, 88045

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Baltimore

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

New York

Columbia University Medical Center, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center Main Campus, New York, New York, United States, 10065

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥ 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, and C)
  • * Presence of RAS G12D mutation (Subprotocol D, E, F)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Revolution Medicines, Inc.,

Study Director, STUDY_DIRECTOR, Revolution Medicines

Study Record Dates

2027-07-15