Status:
RECRUITING
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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) ...
Eligibility Criteria
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
- 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
- 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
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Known clinically significant liver disease
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 25 2029
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT06884618
Start Date
April 30 2025
End Date
May 25 2029
Last Update
January 6 2026
Active Locations (19)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
University of Colorado - Anschutz Medical Campus - PPDS
Aurora, Colorado, United States, 80045
3
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06519-1110
4
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States, 34232