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A Multicenter, Open Label Single Arm Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

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Trial Profile

A Multicenter, Open Label Single Arm Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Nov 2023

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At a glance

  • Drugs Disitamab vedotin (Primary)
  • Indications Bladder cancer; Renal cancer; Ureteral neoplasms; Urogenital cancer
  • Focus Therapeutic Use
  • Sponsors RemeGen

    • Most Recent Events

    • 12 Nov 2023 Results of data analyzed and reported are from RC48-C005 and RC48-C009 trials assessing the efficacy and safety of disitamab vedotin (DV, RC48-ADC), a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E, in patients with HER2-positive locally advanced or metastatic urothelial carcinoma (UC) refractory to standard or regular therapies, published in the Journal of Clinical Oncology.
    • 07 Jun 2022 Results of pooled analysis of the two studies (RC48-C005 and RC48-C009) with the supplementary efficacy, safety and updated OS data presented at the 58th Annual Meeting of the American Society of Clinical Oncology
    • 23 May 2022 According to a RemeGen media release, combined analysis of RC48-C005 and RC48-C009 trials will be presented at a poster discussion session by the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
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