Locally Advanced or Metastatic HER2-Expressing Cancers Clinical Trial
Official title:
A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
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 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 AMX-818 - Part 2 (dose escalation): AMX-818 plus pembrolizumab - Part 3 (dose expansion): Single-agent AMX-818 - Part 4 (dose expansion): AMX-818 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.
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