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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

A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• VIR-5818 (drug)
• pembrolizumab (drug)

Sponsor: Vir Biotechnology, Inc. · Participants: 645 · Started: Apr 13, 2022

Contact the study team

• Study Inquiry · Phone: 415-654-5281

Official record on ClinicalTrials.gov — NCT05356741

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.