This phase I study is evaluating how safe and effective a new targeted therapy (AMX 818) is alone, or in combination with immunotherapy (pembrolizumab) in people with HER2+ cancersA 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

Summary

This dose escalation and dose expansion study has four parts. In Part 1 (dose escalation), participants will receive AMX 818 alone, administered via intravenous (IV) infusion. In Part 2 (dose escalation), participants will receive AMX 818 (via IV) in combination with pembrolizumab (via IV). In Part 3 (dose expansion), participants will receive AMX 818 alone, via IV, at the Recommended Phase 2 Dose. In Part 4 (dose expansion), participants will receive AMX 818 (via IV) at the recommended Phase 2 Dose in combination with pembrolizumab (via IV).

Conditions

This trial is treating patients with locally advanced or metastatic HER2+ cancers, such as breast. bladder, ovarian, pancreatic and stomach cancer.

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