A Phase 1 interventional study of RO7673396 in Neoplasms, sponsored by Hoffmann-La Roche. Recruiting at 25 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression (PD) and/or loss of clinical benefit as determined by the investigator.
Drug: RO7673396
Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or PD and/or loss of clinical benefit as determined by the investigator.
Drug: RO7673396
RO7673396 will be administered as per the schedule specified in the protocol.
Stage I: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 40 months
Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 21
Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Time frame: Up to approximately 40 months
Plasma Concentrations of RO7673396 and its Metabolite(s)
Time frame: Up to approximately 49 months
Stage I: ORR as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1
Time frame: Up to approximately 49 months
Plan to share: No
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Hoffmann-La Roche