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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: 15 Jan 2025

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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

  • 08 Jan 2025 According to RemeGen media release, based on the results of this study Disitamab-vedotin has been approved in China for patients with HER2-overexpressing la/mUC previously treated with platinum-containing chemotherapy.
  • 10 Apr 2024 Pooled analysis results presented at the 115th Annual Meeting of the American Association for Cancer Research
  • 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.

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