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)

A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 345 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DRUG	RO7673396	RO7673396 will be administered as per the schedule specified in the protocol.

Timeline

• Start date: 2025-04-30
• Primary completion: 2028-08-31
• Completion: 2029-05-25
• First posted: 2025-03-19
• Last updated: 2026-03-30

Locations

21 sites across 10 countries: United States, Australia, Canada, China, Denmark, Hong Kong, New Zealand, Singapore, Spain, Taiwan

Regulatory

• FDA-regulated drug study