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)
Condition(s) studied
Investigational drug(s) / intervention(s)
RO7673396: RO7673396 will be administered as per the schedule specified in the protocol.
Study 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.
Eligibility
Primary outcome measure(s)
- Stage I: Number of Participants With Adverse Events (AEs) — Up to approximately 40 months
- Stage I: Number of Participants With Dose-limiting Toxicities (DLTs) — Up to Day 21
- Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) — Up to approximately 40 months
Trial sites (25)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | Recruiting |
| UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS | Aurora | Colorado | Recruiting |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | Recruiting |
| Florida Cancer Specialists - Sarasota (North Catttlemen Rd) | Sarasota | Florida | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | Recruiting |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | Recruiting |
| Peter MacCallum Cancer Center | Parkville | Victoria | Recruiting |
| Princess Margaret Hospital | Toronto | Ontario | Recruiting |
| Sun Yat-Sen University Cancer Center - Huangpu Campus | Guangzhou | Guangdong | Recruiting |
| Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery | Guangzhou | China | Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | China | Recruiting |
| Hubei Cancer Hospital | Wuhan | China | Recruiting |
| Rigshospitalet | København Ø | Denmark | Recruiting |
| Prince of Wales Hospital | Hong Kong | Hong Kong | Recruiting |
| New Zealand Clinical Research - Auckland | Auckland | New Zealand | Recruiting |
| New Zealand Clinical Research - Christchurch | Christchurch | New Zealand | Recruiting |
| National Cancer Centre - 30 Hospital Blvd | Singapore | Singapore | Recruiting |
| Clinica Universidad de Navarra | Pamplona | Navarre | Recruiting |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| National Cheng Kung University Hospital | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei | Taiwan | Recruiting |
| New Queen Elizabeth Hospital Birmingham | Birmingham | West Midlands | Recruiting |
| St Bartholomew's Hospital | London | United Kingdom | Recruiting |
More Hoffmann-La Roche trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06884618 on ClinicalTrials.gov ↗ ← All trials in Spain