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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amunix, a Sanofi Company
• Treatments: Pembrolizumab

Criteria

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

Exclusion criteria:

• Significant cardiopulmonary disease and recent cardiac events

• History of major organ autoimmune diseases

• Acute or chronic infections

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.