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)

What this study is about

This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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

Where this trial is running

• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• University of Colorado - Anschutz Medical Campus - PPDS, Aurora, Colorado, United States
• Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
• Florida Cancer Specialists - Sarasota (North Catttlemen Rd), Sarasota, Florida, United States
• MD Anderson Cancer Center, Houston, Texas, United States
• South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States
• St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
• Peter MacCallum Cancer Center, Parkville, Victoria, Australia
• Princess Margaret Hospital, Toronto, Ontario, Canada
• Sun Yat-Sen University Cancer Center - Huangpu Campus, Guangzhou, Guangdong, China
• Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery, Guangzhou, China
• Fudan University Shanghai Cancer Center, Shanghai, China

+ 9 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06884618.