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

Safety Study of Investigational Medication for HER2-Expressing Cancers

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.

This study investigates the safety and effects of an investigational medication given intravenously, both alone and in combination with another medication, for adults with locally advanced or metastatic HER2-expressing cancers. The study involves different parts to explore how the investigational medication works on its own and alongside the other medication.

Participants will receive the investigational medication through an intravenous line, which means it is given directly into the bloodstream. The study includes different stages to determine the best dose and to observe any side effects. Participants' health and response to the medication will be closely monitored throughout the study.

  • Who can participate: Adults with HER2-expressing cancers who have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1 can participate. Participants must give written informed consent and meet specific health criteria.
  • Study details: Participants will receive the investigational medication intravenously. The study will evaluate the effects of the medication alone and in combination with pembrolizumab. Participants will be monitored for safety and response.
  • Study timelines: The study will last approximately 52 months.
Updated on 07 Jun 2024. Study ID: NCT05356741

Find a study site near you

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
United States Only: Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language