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    DRUG:

    Aidixi (disitamab vedotin)

    i
    Other names: RC48, RC48-ADC, RC 48-ADC, RC 48, RC-48, RC-48-ADC
    Company:
    Pfizer, Rongchang Pharma
    Drug class:
    Microtubule inhibitor, HER2-targeted antibody-drug conjugate
    Related drugs:
    3d
    This study aims to evaluate the efficacy and safety of Disitamab Vedotin combined with Cisplatin and Candelinib in the treatment of patients with locally advanced cervical cancer. (ChiCTR2500114983)
    P=N/A, N=30, Recruiting, Dalian Medical University Second Affiliated Hospital; Dalian Medical University Second Affiliated Hospital
    New trial
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression • HER-2 expression
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    cisplatin • Aidixi (disitamab vedotin) • Kaitanni (cadonilimab)
    3d
    Disitamab Vedotin combining with BCG intravesical instillation versus BCG in HER2 expressed high-risk NMIBC patients: a prospective, multicentre, randomised, phase 3 trial (Formula-02) (ChiCTR2600117601)
    P3, N=164, Not yet recruiting, Sun Yat-sen University Cancer Center (Sun Yat-Sen University Cancer Center, Sun Yat-sen University Cancer Institute); Sun Yat-sen University Cancer Ce
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    Aidixi (disitamab vedotin)
    3d
    Disitamab Vedotin combining with Toripalimab versus adjuvant Toripalimab in HER2 expressed locally advanced UTUC patients after nephron-ureterectory: a prospective, multicentre, open-label, randomised, phase 3 trial (ChiCTR2500115471)
    P3, N=106, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
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    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    3d
    Disitamab Vedotin combining with Toripalimab versus adjuvant Toripalimab in HER2 expressed high-risk MIBC patients after radical cystectomy: a prospective, multicentre, open-label, randomised, phase 3 trial (ChiCTR2500111817)
    P3, N=128, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Loqtorzi (toripalimab-tpzi) • Aidixi (disitamab vedotin)
    3d
    Disitamab Vedotin and Adebrelimab in combination with SOX in the perioperative treatment of HER2-expressing Locally Advanced Esophageal Adenocarcinoma and Esophagogastric Junction Adenocarcinoma: A Prospective, Single-Arm Phase II Study (ChiCTR2500115516)
    P2, N=39, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 expression
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    oxaliplatin • Aidixi (disitamab vedotin) • Teysuno (gimeracil/oteracil/tegafur) • AiRuiLi (adebrelimab)
    3d
    Exploratory Study of Disitamab Vedotin Combination Therapy in Advanced Gastrointestinal Tumors with HER2 Overexpression or Amplification (ChiCTR2500114011)
    P2, N=90, Not yet recruiting, The First Affiliated Hospital of Henan University of Chinese Medicine; The First Affiliated Hospital of Henan University of Chinese Medicine
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • RAS wild-type • HER-2 positive + RAS wild-type
    |
    Erbitux (cetuximab) • Perjeta (pertuzumab) • Lenvima (lenvatinib) • Aidixi (disitamab vedotin)
    3d
    Phase II Trial of Neoadjuvant Disitamab Vedotin Combined with Chemotherapy with or without PD-1 Inhibitor in Locally Advanced HER2-Low (IHC 1+ or IHC 2+/FISH-) Gastric/Gastroesophageal Junction Adenocarcinoma (ChiCTR2500112528)
    P2, N=60, Not yet recruiting, Sun Yat-sen University Cancer Center; Sun Yat-Sen University Cancer Center
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    capecitabine • oxaliplatin • Aidixi (disitamab vedotin)
    4d
    The outcome of disitamab vedotin for the treatment of locally advanced or metastatic extramammary Paget's disease (TxN+M0-1) with high HER2 expression. (ChiCTR2500100703)
    P2, N=23, Completed, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center | Recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Aidixi (disitamab vedotin)
    7d
    Real-World Efficacy and Safety of Disitamab Vedotin (RC48-ADC) in the Treatment of HER2-Overexpressing Advanced Gastric/Gastroesophageal Junction Cancer. (PubMed, Curr Oncol)
    Disitamab vedotin exhibited encouraging anti-tumor effectiveness with a tolerable safety profile for advanced GC/GEJC patients with HER2 overexpression who had failed at least one line of systemic therapy in a real-world setting.
    Retrospective data • Journal • Real-world evidence • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
    |
    Aidixi (disitamab vedotin)
    8d
    BRIGHT: RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure (clinicaltrials.gov)
    P2/3, N=268, Not yet recruiting, Fudan University
    New P2/3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • gemcitabine • capecitabine • Aidixi (disitamab vedotin) • Cipterbin (inetetamab)
    13d
    A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. (clinicaltrials.gov)
    P3, N=555, Recruiting, RemeGen Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 overexpression • HER-2 expression
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Aidixi (disitamab vedotin)
    16d
    Adjuvant bacillus Calmette-Guérin (BCG) immunotherapy versus BCG combined with disitamab vedotin in BCG-naïve high-risk non-muscle invasive bladder cancer with HER2 expression: A real-world study. (PubMed, Int Immunopharmacol)
    Addition of DV to BCG provided favorable early response and superior intermediate-term RFS for BCG-naïve HER2-expressing HR-NMIBC, highlighting its prospect in HR-NMIBC management.
    Journal • Real-world evidence • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Aidixi (disitamab vedotin)