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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:
    3d
    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
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
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    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    16d
    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)
    16d
    SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    22d
    SHR-A1811-Ib/II-205: Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer (clinicaltrials.gov)
    P2, N=258, Recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Active, not recruiting --> Recruiting | N=76 --> 258 | Trial completion date: Jul 2026 --> Dec 2027 | Trial primary completion date: Apr 2025 --> Dec 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    5-fluorouracil • capecitabine • oxaliplatin • trastuzumab rezetecan (SHR-A1811) • retlirafusp alfa (SHR-1701) • AiRuiLi (adebrelimab)
    28d
    Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Shanghai Jiao Tong University School of Medicine
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    docetaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Irene (pyrotinib) • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811)
    28d
    SHR-A1811-I-102: A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors (clinicaltrials.gov)
    P1, N=101, Completed, Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Mar 2025 | Trial primary completion date: Jun 2024 --> Mar 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    trastuzumab rezetecan (SHR-A1811)
    1m
    A Real-World Study of Trastuzumab Rezetecan in HER2+ Solid Tumors (clinicaltrials.gov)
    P=N/A, N=30, Active, not recruiting, Lixiaoling
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)
    1m
    Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08) (clinicaltrials.gov)
    P2, N=111, Recruiting, First Affiliated Hospital of Zhejiang University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • HER-2 positive • HR positive
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Herceptin (trastuzumab) • paclitaxel • Loqtorzi (toripalimab-tpzi) • cyclophosphamide • epirubicin • trastuzumab rezetecan (SHR-A1811)
    1m
    Famitinib Combined With SHR-A1811, Versus SHR-A1811 for CDK4/6 Inhibitors-resistent Advanced HR+/HER2- Breast Cancer With SNF4 Subtype (clinicaltrials.gov)
    P3, N=248, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR positive
    |
    trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020)
    1m
    Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC (clinicaltrials.gov)
    P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of Guangzhou Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    1m
    Trastuzumab rezetecan alone or in combination with adebrelimab in advanced solid tumors with HER2 expression or mutation: a prospective, multicenter, open, nonrandomized, multicohort study. (ChiCTR2500113763)
    P=N/A, N=200, Not yet recruiting, The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation • HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    1m
    Trastuzumab rezetecan (SHR-A1811) combined with bevacizumab in previously treated HER2-altered non-small-cell lung cancer: a phase 2, single-arm study. (ChiCTR2500113565)
    P2, N=60, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Science; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)