Recruiting

RO7673396 for Advanced Solid Tumors with RAS Mutation

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What is being tested

RO7673396

Drug
Who is being recruted

Neoplasms

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: YO45758 https://forpatients.roche.com/
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 30, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new drug called RO7673396 for patients with advanced solid tumors that have specific genetic changes known as RAS mutations. The study's main goal is to understand how safe and tolerable the drug is for these patients, who often have limited treatment options. By finding the best dose of RO7673396 to use, researchers hope this study will lead to more effective treatments and improve the quality of life for people with these challenging cancer types. Participants in the study will receive RO7673396 either on its own or combined with other cancer treatments. The trial is divided into two stages: the first stage will determine the safest dose to use, and the second stage will assess how well this dose works against tumors. This study is carefully designed to monitor any side effects and measure the drug's ability to slow down or shrink the tumors, aiming to find a new treatment option for those affected by RAS-mutated cancers.

Official TitleA 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)
NCT06884618
Principal SponsorHoffmann-La Roche
Study ContactReference Study ID Number: YO45758 https://forpatients.roche.com/
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

345 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neoplasms

Criteria

6 inclusion criteria required to participate
Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors
Participants with measurable disease according to RECIST v1.1 assessed by the investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy ≥12 weeks
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9 exclusion criteria prevent from participating
Current participant or enrollment in another interventional clinical trial
Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
Known and untreated, or active central nervous system (CNS) metastases
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.

Group II

Experimental
Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Recruiting

City of Hope Comprehensive Cancer Center

Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps
Recruiting

University of Colorado - Anschutz Medical Campus - PPDS

Aurora, United States
Recruiting

Smilow Cancer Hospital at Yale New Haven

New Haven, United States
Recruiting

Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

Sarasota, United States
Recruiting
19 Study Centers