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

Investigating Safety and Effects of an Investigational Medication for HER2-Positive Tumors

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, which are tumors that have a protein called Human Epidermal Growth Factor Receptor 2. This protein can promote the growth of cancer cells and is found in some types of cancer. The study is being conducted to understand how the investigational medication works alone and when combined with another medication in treating these tumors.

Participants will be involved in different parts of the study, which include taking the investigational medication by itself or with another medication called pembrolizumab. Pembrolizumab is a type of treatment that helps the immune system fight cancer. The study will look at how the body processes these medications and any effects they have on the tumors.

  • Who can participate: Adults with HER2+ tumors who have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1 can participate. Individuals must provide written informed consent and should not have significant heart or lung disease, recent heart events, or major organ autoimmune diseases.
  • Study details: Participants will receive either the investigational medication alone or in combination with another medication. The study will observe how the body responds to the treatment. The investigational medication is being tested to see if it can be safely used in people with HER2+ tumors.
  • Study Timelines: The study will last approximately 52 months.

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