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

a study on Colorectal Cancer Pancreatic Ductal Adenocarcinoma Gastrointestinal Cancer Solid Tumor Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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 first three 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

Official Title

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

Details

The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI cancers.

This is an open-label platform study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC) or with novel agents, and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be specified in each subprotocol.

Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or patients with previously treated or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

Keywords

Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC, Gastrointestinal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, RAS Mutation, KRAS G12X, Pancreatic Cancer, Pancreatic Ductal Carcinoma, KRAS Q61 Mutation, KRAS G12 Mutation, RAS Wild-type, Colorectal Neoplasms, Adenocarcinoma, Gastrointestinal Neoplasms, Paclitaxel, Bevacizumab, Gemcitabine, Cetuximab, RMC-6236, mFOLFOX6 regimen, mFOLFIRINOX regimen, nab-paclitaxel, metastatic PDAC

Eligibility

You can join if…

Open to people ages 18 years and up

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, and C)

You CAN'T join if...

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.

Locations

  • UCLA Hematology/Oncology- Santa Monica accepting new patients
    Los Angeles California 90404 United States
  • HonorHealth Research Institute accepting new patients
    Scottsdale Arizona 85258 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT06445062
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 406 study participants
Last Updated