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 on Investigational Treatment for HER2+ Tumors
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
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Age: 18 years or above
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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 alone and with another treatment in patients with HER2+ tumors. HER2+ tumors are a type of cancer where human epidermal growth factor receptor 2 is present in high levels, which can cause cancer cells to grow. The purpose of this study is to understand how the investigational medication works and how safe it is for people.
Participants will receive either the investigational medication by itself or in combination with another treatment. Some participants will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will look at how the body processes the medication and any side effects that occur.
- Who can participate: Adults with HER2+ tumors and a life expectancy of at least 12 weeks can participate if they have an ECOG performance status of 0 or 1. Participants must not have significant heart or lung diseases, major autoimmune diseases, or active infections.
- Study details: Participants will receive the investigational medication alone or with another treatment. Some may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines: The study will last 52 months.
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