Back to search results

A Study of RO7673396 for Advanced Solid Tumors with RAS Mutations

This study is testing a drug called RO7673396 for people with advanced solid tumors that have specific changes in their RAS gene (RAS mutation). The main goals are to see if RO7673396 is safe and how well your body handles it. Researchers will also look for early signs that the drug might be shrinking tumors. This study has two parts: first, finding the best dose of RO7673396, and then seeing how well that dose works. You could be eligible if you are 18 or older, have advanced solid tumors with a RAS mutation, and meet other health requirements. The study aims to enroll up to 405 participants. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll up to 405 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tumor response for up to approximately 40 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06884618

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Hoffmann-La Roche
~405 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:RO7673396

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stage I: Number of Participants With Adverse Events (AEs)
Measured over Up to approximately 40 months
+2 more outcomes measured

Conditions

Neoplasms

Explore related trials

Solid NeoplasmRAS Family Oncogene

NCT06884618

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Comprehensive Cancer Center

    Duarte, Californiano site contact published

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, Spainno site contact published

    Recruiting

  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

    Sarasota, Floridano site contact published

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Chinano site contact published

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Chinano site contact published

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • National Cancer Centre - 30 Hospital Blvd

    Singapore, Singaporeno site contact published

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, Taiwanno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Trials · STUDY_DIRECTOR · Hoffmann-La Roche

Who to contact

Reference Study ID Number: YO45758 https://forpatients.roche.com/
[email protected]
888-662-6728 (U.S.)
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
Adequate hematologic and end-organ function
Confirmed presence of the RAS mutation(s)

Exclusion

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
Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment
Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Known clinically significant liver disease

What this trial measures

  • Stage I: Number of Participants With Adverse Events (AEs)Up to approximately 40 months
  • Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)Up to Day 21
  • Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)Up to approximately 40 months