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    DRUG:

    trastuzumab rezetecan (SHR-A1811)

    i
    Other names: SHR-A1811, SHRA1811, SHR A1811, SHR-1811, SHR1811, SHR 1811
    Company:
    Glenmark, Jiangsu Hengrui Pharma
    Drug class:
    Topoisomerase I inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    5d
    A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov)
    P2, N=88, Active, not recruiting, Fudan University | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AR (Androgen receptor)
    |
    HER-2 overexpression • AR positive
    |
    trastuzumab rezetecan (SHR-A1811) • leuprolide acetate for depot suspension • AiRuiEn (rezvilutamide) • tizetatug rezetecan (SHR-A1921)
    5d
    FUSCC Refractory TNBC Platform Study (FUTURE2.0) (clinicaltrials.gov)
    P2, N=120, Recruiting, Fudan University
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • ER negative
    |
    everolimus • AiRuiKa (camrelizumab) • trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020)
    6d
    REIN: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P2, N=150, Recruiting, Henan Cancer Hospital | Trial completion date: Apr 2026 --> Jun 2029 | Trial primary completion date: Oct 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Avastin (bevacizumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    11d
    A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=150, Not yet recruiting, Jiangsu HengRui Medicine Co., Ltd.
    New P2 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
    14d
    SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification
    |
    trastuzumab rezetecan (SHR-A1811) • Yidafan (ivonescimab)
    21d
    Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Fudan University | N=120 --> 160
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive
    |
    trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020) • SHR-A2102 • bulumtatug fuvedotin (9MW2821) • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
    22d
    The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis (clinicaltrials.gov)
    P2, N=184, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting | Initiation date: Nov 2025 --> Mar 2026
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • gemcitabine • capecitabine • albumin-bound paclitaxel • Halaven (eribulin mesylate) • vinorelbine tartrate • trastuzumab rezetecan (SHR-A1811)
    26d
    Study of Multi-mode Thermal Therapy Combined With Immunotherapy In Patients With HER2-negative Breast Cancer With Liver Metastases (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • trastuzumab rezetecan (SHR-A1811) • Jiataile (sacituzumab tirumotecan) • AiRuiLi (adebrelimab)
    26d
    Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=84, Not yet recruiting, Xijing Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Hetronifly (serplulimab)
    27d
    SHR-A1811-307: A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=868, Active, not recruiting, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    1m
    Trastuzumab Rezetecan in Human Epidermal Growth Factor Receptor 2-Expressing Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: A Multicenter, Open-Label, Phase I Trial. (PubMed, J Clin Oncol)
    Trastuzumab rezetecan showed tolerable safety and preliminary efficacy in HER2-expressing advanced GC/GEJ and CRC.
    P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    2ms
    Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, Henan Cancer Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)