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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
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
345
Start Date
2025-04-30
Completion Date
2029-05-25
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
RO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Locations (21)
City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of Colorado - 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
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan