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A Phase II Study to Evaluate the Efficacy and Safety of SKB571 in Recurrent or Metastatic HNSCC Participants

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Enrollment increased: 30 → 120 participants · Interventions modified · Trial arms changed: 1 → 3 · 3 morev2 Show 6 more changesShow less
    • Enrollment increased: 30 → 120 participants
    • Interventions modified
    • Trial arms changed: 1 → 3
    • Start date changed from estimate of Jul 31, 2026 to Jul 27, 2026
    • Study description shortened, about 38 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, open-label, Phase II clinical study to assess the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with recurrent or metastatic HNSCC.
Trial Details
NCT Number NCT07668154
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions HNSCC
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov