A Phase I, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Study Identifier:
AMX-818-001
CT.gov Identifier:
NCT05356741
EudraCT Identifier:
2021-004731-91
EU Trial (CTIS) Number:
2024-516010-38-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate the safety, pharmacokinetics, and preliminary activity of AMX 818 as a single agent and in combination with pembrolizumab in Locally Advanced or Metastatic HER2-Expressing Cancers

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Other
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1 (dose escalation) Participants will receive single-agent VIR-5818 Drug: VIR-5818 Administered as IV infusion Experimental: Part 2 (dose escalation) Participants will receive VIR-5818 plus pembrolizumab Drug: VIR-5818 Administered as IV infusion Drug: pembrolizumab Administered as IV infusion Other Names: KEYTRUDA Experimental: Part 3 (dose expansion) Participants will receive single-agent VIR-5818 Drug: VIR-5818 Administered as IV infusion Experimental: Part 4 (dose expansion Participants will receive VIR-5818 plus pembrolizumab Drug: VIR-5818 Administered as IV infusion Drug: pembrolizumab Administered as IV infusion.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Ramon Yarza
    Status
    Recruiting
    Condition(s) Treated at Site
    Other