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A randomized, open-label, positive-controlled, phase II/III clinical trial of recombinant humanized anti-HER2 monoclonal antibody-AS269 drug conjugate (ARX788) in the treatment of HER2-positive locally advanced or metastatic breast cancer

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Trial Profile

A randomized, open-label, positive-controlled, phase II/III clinical trial of recombinant humanized anti-HER2 monoclonal antibody-AS269 drug conjugate (ARX788) in the treatment of HER2-positive locally advanced or metastatic breast cancer

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 20 Mar 2025

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At a glance

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

Most Recent Events

  • 06 Nov 2024 Status changed from recruiting to completed.
  • 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).

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