Status:
RECRUITING
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
Lead Sponsor:
Vir Biotechnology, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Locally Advanced or Metastatic HER2-Expressing Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 A...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 16 2027
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT05356741
Start Date
April 13 2022
End Date
August 16 2027
Last Update
September 24 2025
Active Locations (10)
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1
Investigational site number #100
Melbourne, Victoria, Australia, 3000
2
Investigational site number #101
Randwick, Australia, 2031
3
Investigational site number #150
Toulouse, France, 31059
4
Investigational site number #200
Porto, Portugal, 4200-072