NCT04014205

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

A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Part 1：r/r B-cell Malignancies
• Part 2：B-cell Malignancies

Interventions

Type	Name	Description
DRUG	Orelabrutinib (ICP-022)	ICP-022 The drug product is a white, round, uncoated tablet

Timeline

• Start date: 2019-11-18
• Primary completion: 2023-12-31
• Completion: 2025-01-30
• First posted: 2019-07-10
• Last updated: 2023-04-18

Locations

36 sites across 4 countries: United States, Israel, Poland, Ukraine

Regulatory

• FDA-regulated drug study