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)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Refr…
Interventions
- DrugRO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Locations (21)
- City of Hope Comprehensive Cancer CenterDuarte, California
- University of Colorado - Anschutz Medical Campus - PPDSAurora, Colorado
- Smilow Cancer Hospital at Yale New HavenNew Haven, Connecticut
- Florida Cancer Specialists - Sarasota (North Catttlemen Rd)Sarasota, Florida
- MD Anderson Cancer CenterHouston, Texas
- South Texas Accelerated Research Therapeutics (START)San Antonio, Texas