Evaluating AMX-818 and Pembrolizumab for HER2-Expressing Cancers
Official title: 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
Run by Vir Biotechnology, Inc. · NCT05356741 · Data updated 2026-11-12
This study is testing a new treatment called AMX-818, alone and with another drug called pembrolizumab, to see if it helps adults with advanced HER2-expressing cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 645 (estimated) |
| Sponsor | Vir Biotechnology, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 12 sites (Duarte, California and 11 other locations) |
| Status | Recruiting |
| Started | April 13, 2022 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT05356741 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with locally advanced or metastatic HER2-expressing tumors who meet specific health criteria.
✕Probably not a fit
Patients with significant cardiopulmonary disease or major organ autoimmune diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is designed to assess the safety and effectiveness of AMX-818, both alone and in combination with pembrolizumab, in adults with locally advanced or metastatic HER2-expressing cancers. The study is structured in four parts, including dose escalation and dose expansion phases for both treatment regimens. Participants will be monitored for safety, pharmacokinetics, and preliminary activity of the treatments over an expected duration of approximately 52 months.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with HER2-expressing cancers.
How similar studies have gone: Other studies have shown promise with similar approaches targeting HER2-expressing cancers, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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City of Hope National Medical Center
Duarte, California, United States Recruiting -
Investigational site number #101
Randwick, Australia Recruiting -
Investigational site number #150
Toulouse, France Recruiting -
Investigational site number #200
Porto, Portugal Recruiting -
Investigational site number #257
Madrid, Madrid, Spain Recruiting -
Investigational site number #255
Barcelona, Spain Recruiting
Show 6 more locations
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Investigational site number #251
Barcelona, Spain Recruiting -
Investigational site number #254
Madrid, Spain Recruiting -
Investigational site number #252
Madrid, Spain Recruiting -
Investigational site number #250
Pamplona, Spain Recruiting -
Investigational site number #253
Pozuelo de Alarcón, Spain Recruiting -
Investigational site number #100
Melbourne, Victoria, Australia Active not recruiting
Study contacts
- Study coordinator: Study Inquiry
- Email: clinicaltrials@vir.bio
- Phone: 415-654-5281
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.