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

Colorectal Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

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 unresectable or metastatic colorectal cancer or 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 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 metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06445062
Study type Interventional
Source Revolution Medicines, Inc.
Contact Revolution Medicines
Phone 650-779-2300
Email CT-inquiries@RevMed.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 24, 2024
Completion date July 15, 2027
View Details
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