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First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

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First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 Dec 2021

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At a glance

  • Drugs Tisotumab-vedotin (Primary)
  • Indications Bladder cancer; Carcinoma; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man
  • Sponsors Genmab; Seagen

    • Most Recent Events

    • 03 Dec 2019 Protocol was amended to allow enrollment of up to an additional 25 patients in the cervival cancer cohort for a maximum of 55 patients in total. Also, another protocol amendment allowed for enrollment of patients on anticoagulants.
    • 03 Dec 2019 Results assessing the safety and antitumor activity of tisotumab vedotin in the cervical cancer expansion cohort (n=55) published in the Clinical Cancer Research.
    • 21 Jun 2019 Status changed from active, no longer recruiting to completed.

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