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ACTIVE NOT RECRUITING
NCT04014205
PHASE1/PHASE2

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

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2019-11-18

Completion Date

2026-06-30

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib (ICP-022)

ICP-022 The drug product is a white, round, uncoated tablet

Locations (36)

Mayo Clinic-Mayo Clinic Hospital-Phoenix

Phoenix, Arizona, United States

Pacific Cancer Medical Center

Anaheim, California, United States

Los Angeles Cancer Network - Good Samaritan Hospital Location

Los Angeles, California, United States

Desert Hematology Oncology Medical Group, Inc.

Rancho Mirage, California, United States

The Oncology Institute of Hope & Innovation

Whittier, California, United States

Florida Cancer Specialists (FCS) South

Fort Myers, Florida, United States

Asclepes Research Centers - Weeki Wachee

Weeki Wachee, Florida, United States

Northwest Neurology - Rolling Meadows Office

Elk Grove Village, Illinois, United States

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

Goshen Center for Cancer Care

Goshen, Indiana, United States

Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

Topeka, Kansas, United States

Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC

New Orleans, Louisiana, United States

Anne Arundel Medical Center (AAMC) Oncology and Hematology

Annapolis, Maryland, United States

Mayo Clinic - Minnesota

Rochester, Minnesota, United States

Coborn Cancer Center

Saint Cloud, Minnesota, United States

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

Summit Medical Group

Florham Park, New Jersey, United States

Clinical Research Alliance

Westbury, New York, United States

Gabrail Cancer Research Center

Canton, Ohio, United States

University of Pittsburgh - Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Guthrie Cancer Center

Sayre, Pennsylvania, United States

Prairie Lakes Cancer Center

Watertown, South Dakota, United States

Tennessee Oncology - Chattanooga Oncology & Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Medical Oncology Associates PS (dba Summit Cancer Centers)

Spokane, Washington, United States

Soroka Medical Center

Beersheba, Israel

Carmel Medical Center

Haifa, Israel

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Cherkassy Regional Oncology Center

Cherkasy, Ukraine

Khmelnytskyi Regional Hospital

Khmelnytskyi, Ukraine

St. Luke's Hospital - Medical and Diagnostic Center

Kropyvnytskyi, Ukraine

National Cancer Institute

Kyiv, Ukraine

Institute of Blood Pathology and Transfusion Medicine

Lviv, Ukraine

Transcarpathian Regional Clinical Hospital named after Andrii Novak

Uzhhorod, Ukraine