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    DRUG CLASS:

    Human TF-targeted antibody-drug conjugate

    Related drugs:
    3d
    Tisotumab Vedotin in Squamous Cell Carcinoma of the Vulva (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, GOG Foundation
    New P2 trial
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    Tivdak (tisotumab vedotin-tftv)
    15d
    Antibody-drug conjugates in gynaecological cancers: opportunities and challenges. (PubMed, Nat Rev Clin Oncol)
    Three ADCs are currently approved for previously treated gynaecological cancers: mirvetuximab soravtansine for folate receptor-α-positive ovarian cancer, trastuzumab deruxtecan for solid tumours expressing HER2 (defined as a staining intensity on immunohistochemistry of 3+) and tisotumab vedotin for cervical cancer (independent of tissue factor expression). Moreover, rational combinations could reinforce and extend the clinical potential of these agents, as has already been demonstrated with the addition of ADCs to immune checkpoint inhibitors in an effort to amplify antitumour immunity and prolong the durability of clinical responses. In this Review, we provide an overview of the current landscape of ADCs in gynaecological malignancies, highlighting key advances and future opportunities.
    Review • Journal • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • FOLR1 ( Folate receptor alpha )
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    HER-2 expression • FOLR1 positive
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • Elahere (mirvetuximab soravtansine-gynx) • Tivdak (tisotumab vedotin-tftv)
    2ms
    A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P3, N=231, Not yet recruiting, Lepu Biopharma Co., Ltd. | Initiation date: Jan 2026 --> Jan 2027
    Trial initiation date
    |
    MRG004A
    2ms
    A Study of SYS6051 in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=114, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P1 trial
    2ms
    MRG004A-001: A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=39, Completed, Shanghai Miracogen Inc. | Recruiting --> Completed | N=181 --> 39
    Trial completion • Enrollment change
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    MRG004A
    2ms
    GCT1015-05: Efficacy and safety of tisotumab vedotin (HuMax-TF-ADC) monotherapy and in combination in recurrent or Stage IVB cervical cancer (2023-508832-68-00)
    P1/2, N=143, Completed, Genmab A/S | Active, not recruiting --> Completed
    Trial completion
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    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Tivdak (tisotumab vedotin-tftv)
    2ms
    Precision oncology in gynecologic cancers: molecular taxonomy, biomarker-guided therapeutics, and the challenge of therapeutic resistance. (PubMed, Front Oncol)
    This has enabled successful clinical translation of targeted agents: PARP inhibitors for homologous recombination deficient (HRD) ovarian cancer, immune checkpoint inhibitors for mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) endometrial and cervical cancers, and antibody-drug conjugates (ADCs) like mirvetuximab soravtansine and tisotumab vedotin. Equitable access to these advances is imperative to prevent widening health disparities. The field is evolving towards a model of continuous molecular monitoring and adaptive therapy to improve outcomes.
    Review • Journal • MSi-H Biomarker • PARP Biomarker • IO biomarker
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    MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency)
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    MSI-H/dMMR
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    Elahere (mirvetuximab soravtansine-gynx) • Tivdak (tisotumab vedotin-tftv)
    2ms
    An Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients with Advanced Solid Tumor (ChiCTR2600120399)
    P1, N=144, Recruiting, Cancer Hospital of Chinese Academy of Medical Sciences; Nanolattix Biotechnology Co., Ltd.
    New P1 trial
    3ms
    Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (clinicaltrials.gov)
    P1/2, N=350, Recruiting, Evopoint Biosciences Inc. | N=200 --> 350
    Enrollment change • First-in-human
    3ms
    KEYNOTE-834: Safety and Efficacy of Tisotumab Vedotin Monotherapy & in Combination With Other Cancer Agents in Subjects With Cervical Cancer (clinicaltrials.gov)
    P1/2, N=214, Terminated, Seagen, a wholly owned subsidiary of Pfizer | Active, not recruiting --> Terminated; Sponsor has decided to stop the trial based on strategic decisions
    Trial termination
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    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • Tivdak (tisotumab vedotin-tftv)
    4ms
    Evaluation of T320, an Anti-Tissue Factor Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=150, Not yet recruiting, Nanolattix Biotechnology Co., Ltd.
    New P1 trial • First-in-human
    4ms
    innovaTV 301: Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov)
    P3, N=502, Completed, Seagen, a wholly owned subsidiary of Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2026 --> Jan 2026
    Trial completion • Trial completion date
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    gemcitabine • pemetrexed • irinotecan • vinorelbine tartrate • topotecan • Tivdak (tisotumab vedotin-tftv)