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An Open-label, Randomized, Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin (ASG-22CE) in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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Trial Profile

An Open-label, Randomized, Phase 1 Safety and Pharmacokinetic Study of Enfortumab Vedotin (ASG-22CE) in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Apr 2022

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At a glance

  • Drugs Enfortumab vedotin (Primary)
  • Indications Bladder cancer; Carcinoma; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Astellas Pharma

    • Most Recent Events

    • 18 Mar 2022 Results assessing thnic differences in pharmacokinetic (PK) profiles of EV and free MMAE using phase 1 trial data from Japanese (EV-102; conducted in Japan) and non-Japanese pts (EV-101; conducted in the US/ Canada) ,presented at the 123rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 18 Mar 2022 Results assessing relationships between EV and MMAE concentrations and QT interval and assesses QT prolongation potential, presented at the 123rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 14 Aug 2019 Results assessing safety/tolerability and pharmacokinetic profiles of EV, as well as antitumor activity and immunogenicity published in the Investigational New Drugs
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