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A Randomized Controlled, Phase 2/3, Pivotal Trial to Evaluate ARX788 in HER2-Positive Breast Cancer Pivotal Trial in China

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A Randomized Controlled, Phase 2/3, Pivotal Trial to Evaluate ARX788 in HER2-Positive Breast Cancer Pivotal Trial in China

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 05 Jul 2024

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At a glance

  • Drugs ARX 788 (Primary)
  • Indications Advanced breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ACE-Breast-02
  • Sponsors Ambrx

    • Most Recent Events

    • 04 Jun 2024 Interim Results(As of Dec. 21, 2022, n=221 patients ) of HER2+ advanced breast cancer patients who progressed on trastuzumab based therapy,presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 01 Mar 2023 According to an Ambrx media release, based on the results from the interim analysis conducted by an Independent Data Monitoring Committee (IDMC), NovoCodex plans to submit a communication application to seek marketing approval in China pending discussion with National Medical Products Administration (NMPA).
    • 01 Mar 2023 Interim results published in the Ambrx Media Release
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