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    DRUG CLASS:

    HER2-targeted antibody-drug conjugate

    Related drugs:
    17h
    Prospective Phase II Clinical Study of Neoadjuvant Therapy with Disitamab Vedotin Combined with Radiotherapy, Sintilimab, and Capecitabine for HER2-Overexpressing Locally Advanced Gastric Cancer (ChiCTR2600118406)
    P2, N=35, Recruiting, Jiangsu Cancer Hospital; Jiangsu Cancer Hospital
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 overexpression
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    Tyvyt (sintilimab) • capecitabine • Aidixi (disitamab vedotin)
    19h
    QL1706 plus Disitamab Vedotin in cisplatin-based chemotherapy resistance or intolerance local advanced or metastatic penile squamous cell carcinoma patients (Bright-01): a prospective, single-arm, open-label, phase 2 study (ChiCTR2600117965)
    P2, N=29, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    cisplatin • Aidixi (disitamab vedotin) • Qibeian (iparomlimab/tuvonralimab)
    20h
    A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=404, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial • Platinum resistant
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    FOLR1 ( Folate receptor alpha )
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    paclitaxel • topotecan • trastuzumab brengitecan (BL-M07D1)
    1d
    MEGA-TACT-BC3: Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer (clinicaltrials.gov)
    P3, N=132, Not yet recruiting, Sun Yat-sen University
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • megestrol
    1d
    A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2 trial
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    HER-2 positive
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    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • anbenitamab repodatecan (JSKN003)
    1d
    Hospital in-use evaluation of the physical, chemical and affinity stability of the antibody-drug conjugate trastuzumab deruxtecan (Enhertu®). (PubMed, Eur J Pharm Sci)
    These results support stability for up to 4 weeks post-reconstitution under our analysis conditions and under appropriate preparation and storage conditions (2-8°C). T-DXd is a blockbuster breast cancer therapy showing excellent results in many clinical trials, so for economic reasons, its use should be rationalized in the future.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    2d
    NeoART: Platform Trial Evaluating Treatment of Neoadjuvant Trastuzumab-deruxtecan Containing Combination Therapies for HER2+, Resectable Esophagogastric Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=36, Active, not recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Suspended --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
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    5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • oxaliplatin
    3d
    SHR-A1811-II-203: A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=324, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Nov 2023 --> Dec 2026
    Trial completion date • Trial primary completion date
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    Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    3d
    TROY: Trastzumab Deruxtecan Versus SOC in Recurrent Ovarian That Progressed on Prior PARP Inhibitor Therapy (clinicaltrials.gov)
    P2, N=116, Recruiting, Yonsei University | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
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    Avastin (bevacizumab) • carboplatin • paclitaxel • Enhertu (fam-trastuzumab deruxtecan-nxki)
    3d
    RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC) (clinicaltrials.gov)
    P3, N=574, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression
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    carboplatin • paclitaxel • Tevimbra (tislelizumab-jsgr) • Aidixi (disitamab vedotin)
    4d
    Impact of less invasive axillary staging procedures after neoadjuvant systemic therapy on adjuvant systemic therapy indications in HER2-positive and triple-negative breast cancer. (PubMed, Eur J Surg Oncol)
    In this cN + cohort, approximately one in six patients eligible for AST had residual disease only in the axilla. Less-invasive axillary staging procedures were associated with a low estimated theoretical risk of missed AST eligibility. However, these findings should be interpreted in light of the modest sample size.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • capecitabine
    4d
    Impact of immune microenvironment on immune checkpoint inhibitor response in HER2-overexpressing urothelial carcinoma. (PubMed, Discov Oncol)
    HER2 expression in urothelial carcinoma was associated with a distinct immune microenvironmental profile characterized by Treg enrichment and relatively low immune checkpoint expression, as supported by our protein-level validation. These findings provide additional biological context for the potential therapeutic benefit of combining RC48 with ICIs. Given the exploratory nature of the HER2-high definition and the limited sample size of the validation cohorts, further prospective studies are warranted to confirm these observations.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L2 (Programmed Cell Death 1 Ligand 2) • FOXP3 (Forkhead Box P3)
    |
    HER-2 overexpression
    |
    Aidixi (disitamab vedotin)