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    DRUG:

    OQY-3258

    i
    Other names: OQY-3258, ESG401, ESG 401, ESG-401, STI 3258, Anti-Trop-2 ADC, STI-3258, STI3258
    Company:
    Escugen Biotechnology, Oqory, Sorrento
    Drug class:
    Topoisomerase I inhibitor, TROP-2-targeted antibody-drug conjugate
    Related drugs:
    23d
    A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=378, Recruiting, Qilu Pharmaceutical Co., Ltd. | Trial completion date: Dec 2026 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • OQY-3258
    2ms
    ESG401-101: Study of ESG401 in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=177, Recruiting, Shanghai Escugen Biotechnology Co., Ltd | Trial completion date: Apr 2025 --> Dec 2025 | Trial primary completion date: Feb 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    OQY-3258
    2ms
    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 | Initiation date: Feb 2025 --> Sep 2025
    Trial initiation date
    |
    carboplatin • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • OQY-3258
    2ms
    Novel TROP2 antibody-drug conjugates for treatment of HER2-negative metastatic breast cancer patients with brain metastases: a promising option☆. (PubMed, ESMO Open)
    These findings suggest that ESG401 is a promising and well-tolerated treatment option for BMs.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    OQY-3258
    7ms
    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) • OQY-3258
    7ms
    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 • OQY-3258
    12ms
    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 • OQY-3258
    1year
    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 • OQY-3258
    over1year
    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) • OQY-3258 • Entyvio (vedolizumab)
    over1year
    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
    |
    OQY-3258