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A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 31, 2023 to Jun 30, 2026 Completion date: Jan 30, 2025 to Jun 30, 2026v17 Show 1 more changeShow less
    • Completion date: Jan 30, 2025 to Jun 30, 2026
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 27 to 36 · Completion date: Nov 30, 2024 to Jan 30, 2025v16 Show 2 more changesShow less
    • Study sites: 27 to 36
    • Completion date: Nov 30, 2024 to Jan 30, 2025
  3. Completion date: Dec 31, 2023 to Nov 30, 2024v15
  4. Study sites: 16 to 27v14
  5. Study sites: 14 to 16v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 7 to 14v12
  2. Primary completion date: Dec 31, 2021 to Dec 31, 2023v11
  3. Re-verified, no change to tracked fieldsv10
  4. Phase: Phase 1 to Phase 1/2 Enrollment target: 15 to 81 · Primary endpoints: 1 to 2 · Interventions: ICP-022 (Drug) to Orelabrutinib (ICP-022) (Drug) · 3 morev9 Show 6 more changesShow less
    • Enrollment target: 15 to 81
    • Primary endpoints: 1 to 2
    • Interventions: ICP-022 (Drug) to Orelabrutinib (ICP-022) (Drug)
    • Eligibility criteria shortened, about 808 words
    • Secondary endpoints: 1 to 5
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Aug 17, 2021 to Dec 31, 2021 Completion date: Jul 3, 2023 to Dec 31, 2023v8 Show 1 more changeShow less
    • Completion date: Jul 3, 2023 to Dec 31, 2023
  6. Primary completion date: Aug 17, 2020 to Aug 17, 2021v7
  7. Re-verified, no change to tracked fieldsv6
  8. Study sites: 8 to 7v5
  9. Site details revised at 5 of 8 sitesv4
  10. Study sites: 7 to 8 Start date changed from estimate of Oct 31, 2019 to Nov 18, 2019v3 Show 1 more changeShow less
    • Start date changed from estimate of Oct 31, 2019 to Nov 18, 2019
  11. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 21, 2019 to Oct 31, 2019 · Study sites: 0 to 7v2 Show 2 more changesShow less
    • Start date: Aug 21, 2019 to Oct 31, 2019
    • Study sites: 0 to 7
  1. 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 I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
Trial Details
NCT Number NCT04014205
Lead Sponsor Beijing InnoCare Pharma Tech Co., Ltd.
Conditions Part 1：r/r B-cell Malignancies, Part 2：B-cell Malignancies
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov