Actively 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
Led by Vir Biotechnology, Inc. · Updated on 2025-09-24
645
Participants Needed
10
Research Sites
278 weeks
Total Duration
On this page
Sponsors
V
Vir Biotechnology, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent by the participant or legally acceptable representative
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diagnosed with locally advanced or metastatic HER2-expressing cancer based on local tests
You will not qualify if you...
- Significant cardiopulmonary disease or recent serious cardiac events
- History of major organ autoimmune diseases
- Presence of acute or chronic infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Investigational site number #100
Melbourne, Victoria, Australia, 3000
Actively Recruiting
2
Investigational site number #101
Randwick, Australia, 2031
Actively Recruiting
3
Investigational site number #150
Toulouse, France, 31059
Actively Recruiting
4
Investigational site number #200
Porto, Portugal, 4200-072
Actively Recruiting
5
Investigational site number #255
Barcelona, Spain, 08023
Actively Recruiting
6
Investigational site number #251
Barcelona, Spain, 08035
Actively Recruiting
7
Investigational site number #254
Madrid, Spain, 28027
Actively Recruiting
8
Investigational site number #252
Madrid, Spain, 28050
Actively Recruiting
9
Investigational site number #250
Pamplona, Spain, 31008
Actively Recruiting
10
Investigational site number #253
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
Research Team
S
Study Inquiry
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here