RecruitingPhase 1Phase 2NCT05356741

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


Sponsor

Vir Biotechnology, Inc.

Enrollment

645 participants

Start Date

Apr 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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 52 months.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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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Interventions

DRUGVIR-5818

Administered as IV infusion

DRUGpembrolizumab

Administered as IV infusion


Locations(10)

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 #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

View Full Details on ClinicalTrials.gov

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NCT05356741