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

  • STATUS
    Recruiting
  • End date
    Aug 16, 2027
  • participants needed
    645
  • sponsor
    Amunix, a Sanofi Company
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Updated on 3 December 2024
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Accepts healthy volunteers

Summary

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.

Details
Condition Locally Advanced or Metastatic HER2-Expressing Cancers
Age 18years or above
Treatment Pembrolizumab, AMX 818, AMX-818
Clinical Study IdentifierNCT05356741
SponsorAmunix, a Sanofi Company
Last Modified on3 December 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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