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A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Aug 31, 2022, no change to tracked fieldsv4-v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 30, 2022 to Jun 14, 2022 · Site details revised at 2 of 2 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Apr 30, 2022 to Jun 14, 2022
    • Site details revised at 2 of 2 sites
  3. Minor Interventions: Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), RC48-ADC (Drug), Triplizumab (Drug) to Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), RC48-ADC (Drug), Toripalimab (Drug) Study description revised · Study title revisedv2 Show 2 more changesShow less
    • Study description revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or Metastatic Urothelial Carcinoma.
Trial Details
NCT Number NCT05302284
Lead Sponsor RemeGen Co., Ltd.
Conditions Urothelial Carcinoma, HER2-expressing
Enrollment 452 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov