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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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllVir Biotechnology, Inc.
NCT05356741 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • VIR-5818
  • pembrolizumab
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Where

12 sites
City of Hope National Medical Center
Duarte, United States
Investigational site number #100
Melbourne, Australia
Investigational site number #101
Randwick, Australia
Investigational site number #150
Toulouse, France
Investigational site number #200
Porto, Portugal
Investigational site number #257
Madrid, Spain
Investigational site number #255
Barcelona, Spain
Investigational site number #251
Barcelona, Spain

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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