VIR-5818 + Pembrolizumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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 72 months.
Who Is on the Research Team?
Clinical Sciences & Operations
Principal Investigator
Sanofi
Are You a Good Fit for This Trial?
This trial is for adults with locally advanced or metastatic cancers that have HER2 protein present, such as certain breast cancers. Participants must be in good physical condition (able to care for themselves), have a life expectancy of at least 12 weeks, and provide informed consent.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- AMX-818
- Pembrolizumab
Trial Overview
Researchers are testing the safety and effects of VIR-5818 given by IV alone or together with pembrolizumab. The study has several parts to find the best dose and see how well these treatments work against HER2-positive tumors.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive VIR-5818 plus pembrolizumab
Participants will receive single-agent VIR-5818
Participants will receive VIR-5818 plus pembrolizumab
Participants will receive single-agent VIR-5818
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.
Lead Sponsor
Amunix, a Sanofi Company
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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