Evaluating AMX-818 and Pembrolizumab for 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
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 |
| Enrollment | 645 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vir Biotechnology, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 10 sites (Melbourne, Victoria and 9 other locations) |
| Trial ID | NCT05356741 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with locally advanced or metastatic HER2-expressing tumors who meet specific health criteria.
Not a fit: Patients with significant cardiopulmonary disease or major organ autoimmune diseases may not benefit from this study.
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 performed: Other studies have shown promise with similar approaches targeting HER2-expressing cancers, indicating potential for success.
Eligibility criteria
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 this trial is running
Melbourne, Victoria and 9 other locations
- Investigational site number #100 — Melbourne, Victoria, Australia (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 #255 — Barcelona, Spain (Recruiting)
- 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)
Study contacts
- Study coordinator: Study Inquiry
- Email: clinicaltrials@vir.bio
- Phone: 415-654-5281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.