RAS Mutations
Research type
Research Study
Full title
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination with other Anticancer Therapies in Patients with Advanced Solid Tumors Harboring RAS Mutation(s).
IRAS ID
1012507
Contact name
EU/ROW Regulatory Affairs Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd.
Clinicaltrials.gov Identifier
Research summary
This study aims to test the safety, tolerability, and effectiveness of RO7673396, a new oral cancer drug designed to block both mutated and normal active RAS proteins. RAS mutations are common in several cancers, including pancreatic cancer (92% of cases), colorectal cancer (49%), and lung cancer (29%).
Mutations in the RAS family of genes are involved in about 30% of human cancers, making them a significant health issue globally. These mutations vary across different types of cancer and are particularly challenging to treat because the RAS protein itself is difficult to target. Traditional treatments like chemotherapy and radiation often don’t work well for RAS-driven cancers, so there is a need for therapies tailored to specific mutations.
This study is a Phase I clinical trial aimed at testing a new drug, RO7673396, which is designed to target cancers with RAS mutations. The goal is to assess its safety, how the body processes it, and its initial effectiveness in treating cancer. Researchers will also test the drug on its own and in combination with two other treatments, bevacizumab and cetuximab, to see how they work together.
The study consists of two stages:
1. Dose Escalation – Finding the safest and most effective dosage for the drug when used alone or in combination with other therapies.
2. Dose Expansion – Testing the effectiveness of the determined doses in treating specific types of cancer.Essentially, this trial is an early step toward developing targeted treatments for cancers that involve RAS mutations, addressing a major gap in cancer therapy.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0329
Date of REC Opinion
27 Nov 2025
REC opinion
Further Information Favourable Opinion