NCT06884618RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 405 (estimated)
- First submitted
- 18 Mar 2025
- Start date
- 30 Apr 2025
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Sarcoma
- NCT number
- NCT06884618
- EU CT number
- 2024-519622-20-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 405
- From 30 Apr 2025 to the primary completion date, 31 Aug 2028
- 25 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption
- 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
Other illness
- Known hypersensitivity or medical contraindication to any component of RO7673396 formulation
- Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD)
- A history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, non-infectious ILD/pneumonitis, or current evidence of active pneumonitis or ILD on screening chest CT scan
- Known clinically significant liver disease
Other
- Current participant or enrollment in another interventional clinical trial
- Known and untreated, or active central nervous system (CNS) metastases
- Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Vincent's Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Peter MacCallum Cancer Center Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sun Yat-Sen University Cancer Center - Huangpu Campus Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Hubei Cancer Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | København Ø | Denmark | Recruiting |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| New Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| St. Bartholomew's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| New Zealand Clinical Research - Auckland Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| New Zealand Clinical Research - Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| National Cancer Centre - 30 Hospital Blvd Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Smilow Cancer Hospital at Yale - New Haven Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| South Texas Accelerated Research Therapeutics (START) Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Florida Cancer Specialists - Sarasota (North Catttlemen Rd) Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.