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.
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
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
Sequential
RO7673396
DrugRO7673396 will be administered as per the schedule specified in the protocol.
Stage I: Number of Participants With Adverse Events (AEs)
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)
Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Plasma Concentrations of RO7673396 and its Metabolite(s)
Stage I: ORR as Assessed by the Investigator per RECIST V1.1
Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1
Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1
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