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A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer

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Trial Profile

A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2025

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At a glance

  • Drugs Bulumtatug Furvedotin (Primary) ; Toripalimab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Urogenital cancer
  • Focus Therapeutic Use
  • Sponsors Mabwell (Shanghai) Bioscience

Most Recent Events

  • 09 Jan 2025 According to a Mabwell Therapeutics media release, 9MW2821 had been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China, as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma that has failed to platinum-based chemotherapy and PD-(L)1 inhibitor therapy.
  • 09 Jan 2025 Results published in the Mabwell Therapeutics Media Release
  • 27 Aug 2024 Status changed from planning to recruiting.

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