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    DRUG CLASS:

    Nectin-4-targeted antibody-drug conjugate

    Related drugs:
    24h
    Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial (clinicaltrials.gov)
    P1/2, N=12, Not yet recruiting, University of Washington
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine • 5-fluorouracil • Padcev (enfortumab vedotin-ejfv) • mitomycin
    1d
    SKB410 for Injection in Solid Tumors (clinicaltrials.gov)
    P1, N=54, Active, not recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
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    MK-3120
    2d
    Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) (clinicaltrials.gov)
    P3, N=390, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine • 5-fluorouracil • Padcev (enfortumab vedotin-ejfv) • mitomycin
    8d
    Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: results from EV-202 cohort 9. (PubMed, Clin Cancer Res)
    EV with pembrolizumab demonstrated promising clinical activity as first-line treatment in patients with PD-L1 CPS ≥1 R/M HNSCC. Safety results reinforced the manageable tolerability profile of EV with pembrolizumab.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
    9d
    Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) (clinicaltrials.gov)
    P3, N=390, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P3 trial
    |
    Keytruda (pembrolizumab) • cisplatin • gemcitabine • 5-fluorouracil • Padcev (enfortumab vedotin-ejfv) • mitomycin
    10d
    Case Report: Complete metabolic responses to trastuzumab-deruxtecan in HER2-altered solid tumors: two illustrative cases. (PubMed, Front Immunol)
    The second case involves a patient with metastatic micropapillary urothelial carcinoma with HER2 expression, refractory to platinum chemotherapy, avelumab maintenance, and enfortumab vedotin. These two observations illustrate the capacity of T-DXd to induce deep and complete metabolic remissions in distinct HER2-altered solid tumors. They support further development of HER2-targeted ADCs beyond traditional indications and highlight the value of FDG-PET/CT for assessing the depth of response to these agents.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression • HER-2 exon 20 insertion • HER-2 exon 20 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)
    14d
    A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002) (clinicaltrials.gov)
    P1/2, N=270, Recruiting, Merck Sharp & Dohme LLC | N=68 --> 270
    Enrollment change
    |
    MK-3120
    14d
    Efficacy of a site-specific anti-Nectin-4 antibody-drug conjugate against Nectin-4-positive triple negative breast cancer models. (PubMed, Int J Pharm)
    Maleimide-linked antibody-drug conjugates (ADC) like Enfortumab Vedotin (EV) have limited in vivo drug-linker stability...Cys2-N4MU01-PMMAE warrants further optimization to enhance its effectiveness against TNBC models. This study also re-enforces the rationale for the development of novel moderate affinity and highly stable targeted therapeutics against other cancers.
    Preclinical • Journal
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    NECTIN4 (Nectin Cell Adhesion Molecule 4)
    |
    Padcev (enfortumab vedotin-ejfv)
    14d
    Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
    P1, N=32, Recruiting, Emory University | Trial completion date: Dec 2026 --> Dec 2028 | Trial primary completion date: Nov 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1)
    |
    Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • Padcev (enfortumab vedotin-ejfv)
    14d
    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 • Halaven (eribulin mesylate) • bulumtatug fuvedotin (9MW2821)
    21d
    A Phase II Clinical Study Based on Endoscopic Laser Ablation Combined with Enfortumab Vedotin and Toripalimab for the Treatment of Localized High-Risk Upper Tract Urothelial Carcinoma (ChiCTR2600121637)
    P2, N=55, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P2 trial
    |
    Loqtorzi (toripalimab-tpzi) • Padcev (enfortumab vedotin-ejfv)
    27d
    DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma (clinicaltrials.gov)
    P2, N=25, Recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    Trial initiation date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)