Brief Summary
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.
Intervention / Treatment
- Drug: AMX-818
- Drug: pembrolizumab
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