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A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
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
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