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)
- Neoplasms
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- Hoffmann-La Roche
- Enrolment target
- 405
- Started
- 30 April 2025
- Main results due
- 31 August 2028
- Study sites
- 25
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Current participant or enrollment in another interventional clinical trial * Known hypersensitivity or medical contraindication to any component of RO7673396 formulation * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption * Known and untreated, or active central nervous system (CNS) metastases * Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD) * 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 * Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study * 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 * 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 * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Known clinically significant liver disease
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(25)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Recruiting
UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS
Aurora, Colorado, United States
Recruiting
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Recruiting
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Recruiting
Peter MacCallum Cancer Center
Parkville, Victoria, Australia
Recruiting
Princess Margaret Hospital
Toronto, Ontario, Canada
Recruiting
Sun Yat-Sen University Cancer Center - Huangpu Campus
Guangzhou, Guangdong, China
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, Spain
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, United Kingdom
Recruiting
St Bartholomew's Hospital
London, United Kingdom
Recruiting
Showing 25 of 25 sites. 25 of the 25 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06884618. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me