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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:
    4d
    Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer (clinicaltrials.gov)
    P2, N=124, Recruiting, The First Affiliated Hospital of Soochow University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)
    7d
    HER2 Therapies in Non-Small Cell Lung Cancer (NSCLC). (PubMed, Int J Mol Sci)
    Concerning treatment, in advanced HER2-positive, Non-Squamous NSCLC tumors, the first-line treatment is Platinum-based + Pemetrexed chemotherapy, with or without immunotherapy, because no HER2-targeted antibody therapy has yet been approved for initial treatment. After progression, HER2-targeted antibody-drug conjugates like Trastuzumab-Deruxtecan and Ado Trastuzumab-Emtansine may offer patients clinical benefits. New HER2-selective tyrosine kinase inhibitors, such as zongertinib and sevabertinib, have shown promising results, including patients previously treated with antibody-drug conjugates (ADCs). Recent advances, including next-generation ADCs such as SHR-A1811 and A166, and bispecific antibodies, such as zenocutuzumab for NRG1 fusion-positive disease, which are also expanding treatment options. Overall, advances in diagnostics and new targeted therapies are changing how HER2-altered NSCLC is treated and are helping to make care more personalized.
    Review • Journal • IO biomarker
    |
    NRG1 (Neuregulin 1)
    |
    HER-2 positive • HER-2 mutation • HER-2 expression • NRG1 fusion • HER-2 exon 20 mutation
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • pemetrexed • Bizengri (zenocutuzumab-zbco) • trastuzumab rezetecan (SHR-A1811) • Hernexeos (zongertinib) • Sertaly (trastuzumab botidotin) • Hyrnuo (sevabertinib)
    9d
    Multi-Omics-Based Phase Ⅱ Trial of Trastuzumab Rezetecan Plus Camrelizumab for Perioperative Therapy in HER2-Positive Muscle-Invasive Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Sheng Tai
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • AiRuiKa (camrelizumab) • trastuzumab rezetecan (SHR-A1811)
    14d
    Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P2 trial
    |
    HER-2 positive
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • trastuzumab rezetecan (SHR-A1811)
    14d
    Trastuzumab Rezetecan(SHR-A1811) Combined With Ivonescimab (AK112) in Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring HER2 Gene Abnormalities (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • Idafang (ivonescimab)
    15d
    SHR-A1811-105: Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=17, Completed, Jiangsu HengRui Medicine Co., Ltd. | N=32 --> 17 | Trial completion date: Aug 2026 --> Oct 2025 | Trial primary completion date: Jun 2025 --> Oct 2025 | Recruiting --> Completed
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    trastuzumab rezetecan (SHR-A1811) • itraconazole • ritonavir
    16d
    Trastuzumab Rezetecan and Adebrelimab as Neoadjuvant Therapy for HER2-Positive Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=58, Not yet recruiting, Harbin Medical University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    18d
    TAYLOR-002: Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=45, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • Irene (pyrotinib) • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811) • Saitanxin (culmerciclib)
    18d
    TD-DASHER-01: Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Tang-Du Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    trastuzumab rezetecan (SHR-A1811) • AiRuiKang (dalpiciclib)
    22d
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Idafang (ivonescimab) • bulumtatug fuvedotin (9MW2821) • AiRuiLi (adebrelimab) • IBI-354 • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
    30d
    Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer (clinicaltrials.gov)
    P4, N=500, Not yet recruiting, Peking University People's Hospital
    New P4 trial • Real-world evidence
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    1m
    Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP (clinicaltrials.gov)
    P4, N=59, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P4 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)