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    DRUG:

    9MW2821

    i
    Other names: 9MW2821
    Company:
    Mabwell (Shanghai) Biosci
    Drug class:
    Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate
    Related drugs:
    4d
    A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P3, N=420, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P3 trial • Metastases
    |
    9MW2821
    2ms
    9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • 9MW2821
    2ms
    9MW2821-2023-CP301: A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=420, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    paclitaxel • docetaxel • 9MW2821
    2ms
    9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=460, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P3 trial • Combination therapy • Metastases
    |
    cisplatin • carboplatin • gemcitabine • Loqtorzi (toripalimab-tpzi) • 9MW2821
    3ms
    Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
    P1, N=30, Recruiting, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    New P1 trial
    |
    9MW2821
    5ms
    A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=160, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P2 trial • Metastases
    |
    9MW2821
    11ms
    A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P3, N=420, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P3 trial • Metastases
    |
    paclitaxel • docetaxel • 9MW2821
    1year
    9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P1/2, N=100, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P1/2 trial • Metastases
    |
    Loqtorzi (toripalimab-tpzi) • 9MW2821
    over1year
    Preclinical Evaluation of 9MW2821, a Site-Specific Monomethyl Auristatin E-based Antibody-Drug Conjugate for treatment of Nectin-4-expressing Cancers. (PubMed, Mol Cancer Ther)
    Enfortumab vedotin (EV) is the first nectin-4-targeting antibody-drug conjugate (ADC) approved by the FDA for the treatment of urothelial cancer. Overall, 9MW2821 is a nectin-4-directed, investigational antibody-drug conjugate based on innovative technology that endowed the drug with compelling preclinical antitumor activity and a favorable therapeutic index. The 9MW2821 antibody-drug conjugate is being investigated in a Phase I/II clinical trial (NCT05216965) in patients with advanced solid tumors.
    Preclinical • Journal
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    NECTIN4 expression
    |
    Padcev (enfortumab vedotin-ejfv) • 9MW2821
    over1year
    Preliminary results from a phase I/II study of 9MW2821, an antibody-drug conjugate targeting nectin-4, in patients with advanced solid tumors (ESMO 2023)
    Conclusions The results showed that 9MW2821 had manageable safety profile and promising antitumor activity. Enrollment continues to determine efficacy of 9MW2821 in certain solid tumors.
    Clinical • P1/2 data • Metastases
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    NECTIN4 expression
    |
    9MW2821
    over2years
    A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=208, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jun 2022
    Enrollment open • Trial initiation date
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    NECTIN4 expression
    |
    9MW2821
    almost3years
    A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=208, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P1/2 trial
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    NECTIN4 expression
    |
    9MW2821