RECRUITING Phase 1 ClinicalTrials.gov

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)

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT06884618

Registry updated: 2026-09-28

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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.

Interventions

RO7673396 (Drug)
RO7673396 will be administered as per the schedule specified in the protocol.

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

Conditions

Neoplasms

Locations

City of Hope Comprehensive Cancer Center — Duarte, California, United States
UCHealth Lung Cancer Clinic - Anschutz Medical Campus - PPDS — Aurora, Colorado, United States
Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
Florida Cancer Specialists - Sarasota (North Catttlemen Rd) — Sarasota, Florida, United States
MD Anderson Cancer Center — Houston, Texas, United States
South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas, United States
St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
Peter MacCallum Cancer Center — Parkville, Victoria, Australia
Princess Margaret Hospital — Toronto, Ontario, Canada
Sun Yat-Sen University Cancer Center - Huangpu Campus — Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery — Guangzhou, China
Fudan University Shanghai Cancer Center — Shanghai, China
Hubei Cancer Hospital — Wuhan, China
Rigshospitalet — København Ø, Denmark
Prince of Wales Hospital — Hong Kong, Hong Kong
New Zealand Clinical Research - Auckland — Auckland, New Zealand
New Zealand Clinical Research - Christchurch — Christchurch, New Zealand
National Cancer Centre - 30 Hospital Blvd — Singapore, Singapore
Clinica Universidad de Navarra — Pamplona, Navarre, Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
National Cheng Kung University Hospital — Tainan, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
New Queen Elizabeth Hospital Birmingham — Birmingham, West Midlands, United Kingdom
St Bartholomew's Hospital — London, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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