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

Last updated: June 6, 2024
Sponsor: Amunix, a Sanofi Company
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Pembrolizumab

pembrolizumab

AMX-818

Clinical Study ID

NCT05356741
AMX-818-001
TCD17730
2021-004731-91
MK-3475-D14
KEYNOTE-D14
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Written informed consent by the participant (or legally acceptable representative ifapplicable)

  • 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 factorreceptor 2 (HER2) status, per local tests

Exclusion

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.

Study Design

Total Participants: 645
Treatment Group(s): 3
Primary Treatment: Pembrolizumab
Phase: 1/2
Study Start date:
April 13, 2022
Estimated Completion Date:
August 16, 2027

Connect with a study center

  • Investigational site number #100

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Investigational site number #101

    Randwick, 2031
    Australia

    Active - Recruiting

  • Investigational site number #150

    Toulouse, 31059
    France

    Active - Recruiting

  • Investigational site number #200

    Porto, 4200-072
    Portugal

    Active - Recruiting

  • Investigational site number #251

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Investigational site number #255

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Investigational site number #252

    Madrid, 28050
    Spain

    Active - Recruiting

  • Investigational site number #254

    Madrid, 28027
    Spain

    Active - Recruiting

  • Investigational site number #250

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Investigational site number #253

    Pozuelo de Alarcón, 28223
    Spain

    Active - Recruiting

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