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    DRUG:

    ESG401

    i
    Other names: ESG401, ESG 401, ESG-401, Anti-Trop-2 ADC, STI-3258, STI3258, STI 3258
    Company:
    Escugen Biotechnology, Sorrento
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
    5d
    A Phase III Study of ESG401 for Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=504, Not yet recruiting, Shanghai Escugen Biotechnology Co., Ltd
    New P3 trial • Metastases
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • ESG401
    6d
    Case report: Prolonged benefit of ESG401, a Trop2 antibody-drug conjugate, in endocrine-refractory hormone receptor-positive, HER-2 negative metastatic breast cancer. (PubMed, Front Oncol)
    We report a case of a 61-year-old female with HR+HER2- metastatic breast cancer (MBC) who developed resistance to fulvestrant and subsequent chemotherapy but achieved a durable partial response (PR) lasting more than 22.5 months following ESG401 treatment. Furthermore, the patient's exceptionally long clinical benefit distinguishes her from other patients receiving ESG401 treatment. Further exploration of the use of ESG401 in HR+HER2- MBC patients, as well as a deeper understanding of the characteristics of patients that may impact sustained efficacy, in expanded clinical trials is warranted.
    Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    fulvestrant • ESG401
    5ms
    A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=378, Recruiting, Shanghai Escugen Biotechnology Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • ESG401
    8ms
    A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=378, Not yet recruiting, Shanghai Escugen Biotechnology Co., Ltd
    New P3 trial • Metastases
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • ESG401
    9ms
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=30, Recruiting, Peking Union Medical College | Initiation date: Dec 2023 --> May 2024
    Trial initiation date • Metastases
    |
    cisplatin • erlotinib • carboplatin • sorafenib • AiTan (rivoceranib) • albumin-bound paclitaxel • abiraterone acetate • bicalutamide • larotinib (Z650) • ESG401 • Entyvio (vedolizumab)
    12ms
    Study of ESG401 in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=177, Recruiting, Shanghai Escugen Biotechnology Co., Ltd
    Trial completion date • Trial primary completion date • Metastases
    |
    ESG401