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 of Investigational Medication for HER2+ Tumors (a type of protein that can affect cancer growth)

Recruiting
18 years or above
All
Phase 1/2
645 participants needed
2 Locations

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 or above
  • 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 07 Jun 2024. Study ID: NCT05356741

This study investigates the safety and effects of an investigational medication in people with HER2+ tumors. HER2+ tumors are a type of cancer that has a high level of a protein called human epidermal growth factor receptor 2, which can affect how cancer cells grow. The study will test the investigational medication alone and in combination with another medication.

Participants will receive the investigational medication in different parts of the study. Some will receive only the investigational medication, while others will receive it with an additional medication. The study will monitor how the body processes the medication and any effects it has on the tumors.

  • Who can participate: Participants must have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1. They must have HER2+ tumors as confirmed by local tests. Certain health conditions, such as significant heart or lung disease, autoimmune diseases, or infections, may exclude participants.
  • Study details: Participants will take part in a study where they receive either the investigational medication alone or with another medication. The study will assess the safety and effects of the treatments. A placebo is not used in this study.
  • Study timelines: The study will last approximately 52 months.

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