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A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 7 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Enrollment target: 68 to 75 Site details revised at 28 of 29 sitesv4 Show 1 more changeShow less
    • Site details revised at 28 of 29 sites
  3. Study title expanded, about 1 wordv3 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2025 to Dec 2027 · Study sites: 28 to 29 · Start date changed from estimate of Jul 18, 2025 to Aug 21, 2025v2 Show 3 more changesShow less
    • Primary completion date: Dec 2025 to Dec 2027
    • Study sites: 28 to 29
    • Start date changed from estimate of Jul 18, 2025 to Aug 21, 2025
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.
Trial Details
NCT Number NCT07082686
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov