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OncoMatch/Clinical Trials/NCT06884618

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)

Is NCT06884618 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies RO7673396 for neoplasms.

Phase 1RecruitingHoffmann-La RocheNCT06884618Data as of May 2026

Treatment: RO7673396This 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.

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Extracted eligibility criteria

Biomarker criteria

Required: KRAS mutation

Confirmed presence of the RAS mutation(s)

Required: NRAS mutation

Confirmed presence of the RAS mutation(s)

Required: HRAS mutation

Confirmed presence of the RAS mutation(s)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: chemotherapy

Exception: within 4 weeks or five half-lives prior to initiation of study treatment

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

Cannot have received: immunotherapy

Exception: within 4 weeks or five half-lives prior to initiation of study treatment

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

Cannot have received: biologic therapy

Exception: within 4 weeks or five half-lives prior to initiation of study treatment

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

Cannot have received: investigational agent

Exception: within 4 weeks or five half-lives prior to initiation of study treatment

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

Lab requirements

Blood counts

adequate hematologic function

Kidney function

adequate end-organ function

Liver function

adequate end-organ function

Adequate hematologic and end-organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Comprehensive Cancer Center · Duarte, California
  • University of Colorado - Anschutz Medical Campus - PPDS · Aurora, Colorado
  • Smilow Cancer Hospital at Yale New Haven · New Haven, Connecticut
  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd) · Sarasota, Florida
  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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