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)

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.

Trial Details

NCT ID
NCT06884618
Phase
PHASE1
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • RO7673396
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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