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)

Launched by HOFFMANN-LA ROCHE · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called RO7673396 to see how safe it is and how well it might work for people with advanced solid tumors that have a specific genetic change known as a RAS mutation. The study has two parts: the first part will help determine the best dose of RO7673396 to use, and the second part will look at how well the medication can help reduce tumors in patients.

To be eligible for this trial, participants should have a type of cancer that is advanced and cannot be cured, and they need to have measurable disease. They must also be in relatively good health with a life expectancy of at least 12 weeks. However, some people may not qualify if they have certain medical conditions or if they are currently involved in another clinical trial. Participants in the trial can expect to receive the study medication and will be closely monitored by healthcare professionals for any side effects or changes in their condition. This trial is currently looking for volunteers, and it welcomes individuals of all genders aged 65 and older.

Gender

ALL

Eligibility criteria

• 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
• • 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
• • 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