Overview

To Access the Safety and Effects of Intravenous Administration of AMX 818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Status:
Recruiting

Trial end date:
2026-12-09

Target enrollment:

Participant gender:

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 at the recommended Phase 2 dose (RP2D). - Part 4 (dose expansion): AMX 818 at the RP2D 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.

Phase:

Phase 1

Details

Lead Sponsor:

Amunix, a Sanofi Company

Treatments:

Pembrolizumab