Tests RO7673396 in adults with advanced solid tumors carrying RAS mutations
Tests the drug RO7673396 in adults with advanced solid tumors that have RAS mutations.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Darlinghurst and Parkville, AustraliaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that cannot be cured and that carry a RAS mutation. It tests the safety of the drug RO7673396.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced, recurrent or metastatic solid tumors that cannot be cured, with disease that can be measured by RECIST v1.1
- Earlier treatment
- No chemotherapy, immunotherapy, biologic therapy or investigational anti-cancer drug within 4 weeks or five half-lives before starting study treatment
- Biomarker or test result
- Confirmed RAS mutation(s)
Main reasons for not taking part
- Taking part in another interventional clinical trial
- Known or active brain or spinal cord (CNS) metastases that are untreated
- History of lung scarring or inflammation (pulmonary fibrosis, pneumonitis, ILD)
- Bowel problems that stop the drug being absorbed (such as chronic diarrhea, short bowel syndrome, inflammatory bowel disease)
- Major surgery within 28 days before starting study treatment
Read by machine on 9 November 2026.
Where in Australia
- St Vincent's Hospital SydneyDarlinghurst, AustraliaTaking people
- Peter MacCallum Cancer CenterParkville, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT06884618EU 2024-519622-20-00
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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; 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.