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 (dosethe amount of medication taken 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. by the participant (or legally acceptable representative if applicable)
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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