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    DRUG:

    bulumtatug fuvedotin (9MW2821)

    i
    Other names: 9MW2821, 9MW 2821, 9MW-2821, BFv
    Company:
    Mabwell (Shanghai) Biosci
    Drug class:
    Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate
    Related drugs:
    12d
    CVL006-T1003: Clinical Study of CVL006 Combination With 9MW2821 (clinicaltrials.gov)
    P1/2, N=108, Not yet recruiting, Convalife (Shanghai) Co., Ltd.
    New P1/2 trial
    |
    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    bulumtatug fuvedotin (9MW2821)
    13d
    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)
    1m
    A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=356, Not yet recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P3 trial
    |
    capecitabine • eribulin mesylate • bulumtatug fuvedotin (9MW2821)
    3ms
    Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=160, Recruiting, Fudan University | N=120 --> 160
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HR positive
    |
    trastuzumab rezetecan (SHR-A1811) • famitinib (SHR 1020) • SHR-A2102 • bulumtatug fuvedotin (9MW2821) • ruzaltatug rezetecan (SHR-A2009) • tizetatug rezetecan (SHR-A1921)
    4ms
    NECTAR Study: Neoadjuvant Toripalimab + 9MW2821 for Local UTUC (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Peking University Third Hospital
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • bulumtatug fuvedotin (9MW2821)
    4ms
    An open-label, single-center, randomized controlled phase II clinical study evaluating the safety and efficacy of neoadjuvant therapy with radiotherapy plus toripalimab versus 9MW2821 plus toripalimab in patients with upper tract urothelial carcinoma (UTUC) (ChiCTR2600117688)
    P2, N=60, Not yet recruiting, Peking University Third Hospital; Peking University Third Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi) • bulumtatug fuvedotin (9MW2821)
    5ms
    9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer (clinicaltrials.gov)
    P2, N=90, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd.
    New P2 trial • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Loqtorzi (toripalimab-tpzi) • bulumtatug fuvedotin (9MW2821)
    7ms
    Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules. (PubMed, Front Mol Med)
    Enfortumab vedotin is an NECTIN4-targeting antibody-drug conjugate that is approved for the treatment of urothelial cancer, whereas other ADCs or derivatives that target NECTIN4, such as bulumtatug fuvedotin, SHR-A2102 and zelenectide pevedotin, are being studied in randomized phase III clinical trials. In contrast, arcotatug tavatecan, garetatug rezetecan, sonesitatug vedotin and tecotabart vedotin are anti-CLDN18.2 ADCs in phase III clinical trials for the treatment of CLDN18.2-positive gastric or gastroesophageal junction adenocarcinomas, and raludotatug deruxtecan is an anti-CDH6 ADC in a phase II/III clinical trial for the treatment of platinum-resistant ovarian cancer. ADCs that target cell-cell adhesion molecules are a rapidly emerging class of cancer therapeutics, and bispecific ADCs and longitudinal companion diagnostics are emerging to further improve the clinical benefits of conventional ADCs.
    Review • Journal
    |
    CLDN18 (Claudin 18) • CLDN6 (Claudin 6) • CDH6 (Cadherin 6) • CDH17 (Cadherin 17)
    |
    CLDN18.2 positive
    |
    Padcev (enfortumab vedotin-ejfv) • sonesitatug vedotin (AZD0901) • tecotabart vedotin (LM-302) • zelenectide pevedotin (BT8009) • SHR-A2102 • arcotatug tavatecan (TAK-921) • bulumtatug fuvedotin (9MW2821) • garetatug rezetecan (SHR-A1904) • raludotatug deruxtecan (DS-6000)
    8ms
    Structural basis of nectin-4 recognition by the antibody-drug conjugate 9MW2821. (PubMed, J Biol Chem)
    Based on the structure of nectin-4 D1/9MW2821 Fab complex resolved in this study, we have elucidated the molecular mechanism of 9MW2821 in cancer therapy. The findings provide a basis for optimizing future monoclonal antibodies targeting nectin-4.
    Journal
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4) • NECTIN1 (Nectin Cell Adhesion Molecule 1)
    |
    bulumtatug fuvedotin (9MW2821)
    8ms
    JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • bulumtatug fuvedotin (9MW2821)
    10ms
    A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs (clinicaltrials.gov)
    P1, N=52, Recruiting, Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: May 2025 --> Aug 2025
    Enrollment open • Trial initiation date
    |
    bulumtatug fuvedotin (9MW2821)
    11ms
    JS207 Combination Therapy in Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    albumin-bound paclitaxel • bulumtatug fuvedotin (9MW2821)