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Sponsor: Vir Biotechnology, Inc.
Conditions: Locally Advanced or Metastatic HER2-Expressing Cancers
Interventions: VIR-5818, pembrolizumab
Countries: United States, Australia, France, Portugal, Spain
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Duarte, California, United States
- Melbourne, Victoria, Australia
- Randwick, Australia
- Toulouse, France
- Porto, Portugal
- Madrid, Madrid, Spain
- Barcelona, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Pamplona, Spain
- Pozuelo de Alarcón, Spain