Safety and Efficacy of RO7673396 Monotherapy and Combination Therapy in Patients with Advanced RAS-Mutant Solid Tumors
- Trial ID
- 2024-519622-20-00
- Protocol
- YO45758
- Sponsor
- F. Hoffmann-La Roche AG
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the safety and tolerability of RO7673396, administered as a monotherapy or in combination with other oncological medications, in patients diagnosed with advanced solid tumors harboring RAS mutations. Assessing these parameters is clinically essential to establish the risk profile and acceptable dosage levels for this therapeutic agent within this specific patient population. 4, 5
Participants
The study involves a total of 275 patients. The population includes both male and female individuals. The participants are identified within specific age range categories. The study subjects are characterized by the presence of advanced solid tumors harboring RAS mutations. This cohort includes vulnerable populations.
Plans and Procedures
This Phase 1 clinical trial is designed to assess the safety, tolerability, and efficacy of RO7673396, administered either as a monotherapy or in combination with other oncology medications. The study focuses on participants diagnosed with advanced solid tumors harboring RAS mutations. The research methodology involves a sequence of study visits beginning with a screening visit to determine eligibility. Subsequent follow-up visits will be conducted to monitor clinical responses and safety profiles, concluding with an end-of-study visit. Total participant involvement duration is determined by individual clinical progression or protocol requirements. Early termination from the study may occur based on specific clinical conditions or safety criteria defined within the protocol.
Treatment
Efficacy
Efficacy in this study of advanced solid tumors harboring RAS mutations will be evaluated according to the clinical trial protocol. The specific parameters, assessment methods, and measurement schedules for evaluating therapeutic response are not defined in the provided documentation.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
Belgium | Not Yet Recruiting | 01 Jan 2026 | 10 |
Denmark | Recruiting | 01 Jan 2026 | 10 |
France | Not Yet Recruiting | 01 Jan 2026 | 10 |
Germany | Not Yet Recruiting | 01 Jan 2026 | 10 |
The Netherlands | Not Yet Recruiting | 01 Jan 2026 | — |
Spain | Recruiting | 01 Jan 2026 | 20 |
Netherlands | — | — | 10 |






