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

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Locally Advanced or Metastatic HER2-Expressing Cancers
  • Age: 18 Years
  • Gender: All

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.

Updated on 08 Mar 2024. Study ID: NCT05356741

Find a Study Location to Connect

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site