Clinical Trial

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

Active, Not Recruiting Phase 1/2
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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.
Summary
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).
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2019-07-09; most recent amendment 2026-06-05.
Status change: Recruiting → Active, Not Recruiting 2023-04-14
Status change: Not Yet Recruiting → Recruiting 2019-10-09
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 2019-11-18
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-08