Study on RAS(ON) Inhibitors for Patients with Gastrointestinal Solid Tumors

Sponsor: Revolution Medicines, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06445062

Provider View

This clinical trial is testing new RAS(ON) inhibitors combined with standard treatments or new drugs to see if they are safe and effective for patients with gastrointestinal cancers that have a RAS mutation.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of new RAS(ON) inhibitors when used with standard cancer treatments or new drugs in patients with gastrointestinal cancers that have a RAS mutation. The study includes three parts: Subprotocol A tests RMC-6236 with 5-fluorouracil-based treatments, Subprotocol B tests RMC-6236 with cetuximab, with or without mFOLFOX6, and Subprotocol C tests RMC-6236 with gemcitabine and nab-paclitaxel.

Description

This study is designed to test new RAS(ON) inhibitors in combination with other cancer treatments for patients with RAS-mutated solid tumors, focusing on gastrointestinal cancers. The study is open-label, meaning both doctors and patients know what treatment is being given. It aims to find the best dose and schedule for these new drugs.

Subprotocol A involves RMC-6236 combined with 5-fluorouracil-based treatments for patients with colorectal cancer or pancreatic cancer that cannot be removed by surgery or has spread. Subprotocol B involves RMC-6236 combined with cetuximab, with or without mFOLFOX6, for similar patients. Subprotocol C involves RMC-6236 combined with gemcitabine and nab-paclitaxel for patients with pancreatic cancer that has spread. Each subprotocol has two parts: Part 1 explores different doses, and Part 2 expands on the best dose found.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities
  • Have adequate organ function as required by the study
  • Have a confirmed diagnosis of pancreatic cancer or colorectal cancer with a RAS mutation that cannot be removed by surgery or has spread

Exclusion Criteria

  • Have primary tumors in the central nervous system (CNS)
  • Have gastrointestinal (GI) issues that could affect the absorption of the study drugs
  • Have had major surgery within 28 days before starting the study
  • Other criteria may apply

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