Evaluating a new treatment for advanced solid tumors with RAS mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of RO7673396 in patients with advanced solid tumors that have RAS mutations. It consists of two stages: the first stage focuses on determining the recommended doses for further testing, while the second stage assesses the preliminary anti-tumor activity of these doses. Participants will be closely monitored for any adverse effects and the effectiveness of the treatment. The study aims to provide insights into the potential of RO7673396 as a therapeutic option for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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
* A history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, non-infectious ILD/pneumonitis, or current evidence of active pneumonitis or ILD on screening chest CT scan
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Known clinically significant liver disease

Where it's running

• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS
  Aurora, Colorado, United States Recruiting
• Smilow Cancer Hospital at Yale New Haven
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
  Sarasota, Florida, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• South Texas Accelerated Research Therapeutics (START)
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: YO45758 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S.)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.