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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

To Access the Safety and Effects of Intravenous Administration of VIR-5818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Sponsor: Vir Biotechnology, Inc. • ClinicalTrials.gov ID: NCT05356741

Registry updated: 2026-08-19
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Description

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of VIR-5818 (Formerly AMX-818) as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: * Part 1 (dose escalation): Single-agent VIR-5818 * Part 2 (dose escalation): VIR-5818 plus pembrolizumab * Part 3 (dose expansion): Single-agent VIR-5818 * Part 4 (dose expansion): VIR-5818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 72 months.

Interventions

  • VIR-5818 (Drug)
    Administered as IV infusion
  • pembrolizumab (Drug)
    Administered as IV infusion

Eligibility criteria

Inclusion criteria: * Written informed consent by the participant (or legally acceptable representative if applicable) * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Diseases under study, prior lines of therapy, and human epidermal growth factor receptor 2 (HER2) status, per local tests Exclusion criteria: * Significant cardiopulmonary disease and recent cardiac events * History of major organ autoimmune diseases * Acute or chronic infections The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Conditions

Locally Advanced or Metastatic HER2-Expressing Cancers

Locations

  • City of Hope National Medical Center — Duarte, California, United States
  • Investigational site number #100 — Melbourne, Victoria, Australia
  • Investigational site number #101 — Randwick, Australia
  • Investigational site number #150 — Toulouse, France
  • Investigational site number #200 — Porto, Portugal
  • Investigational site number #257 — Madrid, Madrid, Spain
  • Investigational site number #255 — Barcelona, Spain
  • Investigational site number #251 — Barcelona, Spain
  • Investigational site number #254 — Madrid, Spain
  • Investigational site number #252 — Madrid, Spain
  • Investigational site number #250 — Pamplona, Spain
  • Investigational site number #253 — Pozuelo de Alarcón, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record