Clinical Trial

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 Phase 1
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Summary
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.
Protocol Amendment History 1 change
notable Enrollment increased: 345 -> 405 participants 2026-04-22
Trial Details
NCT Number NCT06884618
Lead Sponsor Hoffmann-La Roche
Conditions Neoplasms
Enrollment 405 participants
Start Date 2025-04-30
Primary Completion 2028-08-31 (estimated)
Study Completion 2029-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-04-21