A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Trial Profile

A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Mar 2018

At a glance

  • Drugs Enfortumab vedotin (Primary)
  • Indications Fallopian tube cancer; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer; Solid tumours; Urogenital cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Agensys; Astellas Pharma; Astellas Pharma Global Development
  • Most Recent Events

    • 26 Mar 2018 According to an Astellas Pharma media release, the US FDA has granted Breakthrough therapy designation to Enfortumab-vedotin based on the interim results of this trial.
    • 10 Feb 2018 Results (n=62; Data cut off 2 Oct 2017) of analysis assessing clinical profile of Enfortumab vedotin in metastatic urogenital cancer patients with checkpoint inhibitor failure presented at the 2018 Genitourinary Cancers Symposium
    • 09 Jan 2018 Planned number of patients changed from 200 to 215.
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