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Active, not recruiting Phase 1/2

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

NCT04014205 · tracked via the Priya Life Science Poland tracker
Phase
Phase 1/2
Started
2019-11-18
Last updated
2026-06-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Orelabrutinib (ICP-022) →

Orelabrutinib (ICP-022): ICP-022 The drug product is a white, round, uncoated tablet

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Signed Informed Consent. 2. Age ≥ 18 years. 3. Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL. Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment. 4. Life expectancy (in the opinion of the investigator) of ≥ 4 months. 5. ECOG performance status of 0 \~1. 6. Must have adequate organ function. 7. Negative test results for HBV (\[HBsAg (-)\] and non-active HBV or HCV infection Exclusion Criteria: 1. Pregnant or breast-feeding or intending to become pregnant during the study. 2. Prior treatment with systemic immunotherapeutic agents. 3. Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV. 4. Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug. 5. History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML. 6. Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug. 7. Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor. 8. Active uncontrolled infections. 9. Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug. 10. Unresolved toxicities from prior anti-cancer therapy. 11. Medically apparent CNS lymphoma or leptomeningeal disease. 12. Current or previous history of CNS disease. 13. Major surgery or significant traumatic injury \< 28 days prior to the first dose of the study drug. 14. Patients with another invasive malignancy in the last 2 years. 15. Significant cardiovascular disease or active pulmonary disease. 16. Received systemic immunosuppressive medications.

Primary outcome measure(s)

  • Part 1 Dose Escalation:The maximum tolerated dose (MTD) — Incidence of dose limiting toxicities (DLTs) up to 28 days
    To determine the maximum tolerated dose (MTD)
  • Part 2 Dose Expansion:ORR — Up to 2 years
    To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.

Trial sites (36)

FacilityCityRegionStatus
Mayo Clinic-Mayo Clinic Hospital-Phoenix Phoenix Arizona
Pacific Cancer Medical Center Anaheim California
Los Angeles Cancer Network - Good Samaritan Hospital Location Los Angeles California
Desert Hematology Oncology Medical Group, Inc. Rancho Mirage California
The Oncology Institute of Hope & Innovation Whittier California
Florida Cancer Specialists (FCS) South Fort Myers Florida
Asclepes Research Centers - Weeki Wachee Weeki Wachee Florida
Northwest Neurology - Rolling Meadows Office Elk Grove Village Illinois
Orchard Healthcare Research Inc. Skokie Illinois
Goshen Center for Cancer Care Goshen Indiana
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center) Topeka Kansas
Tulane University School of Medicine - Tulane Cancer Center Comprehensive Clinic TCCCC New Orleans Louisiana
Anne Arundel Medical Center (AAMC) Oncology and Hematology Annapolis Maryland
Mayo Clinic - Minnesota Rochester Minnesota
Coborn Cancer Center Saint Cloud Minnesota
Southeast Nebraska Cancer Center Lincoln Nebraska
Summit Medical Group Florham Park New Jersey
Clinical Research Alliance Westbury New York
Gabrail Cancer Research Center Canton Ohio
University of Pittsburgh - Hillman Cancer Center Pittsburgh Pennsylvania
Guthrie Cancer Center Sayre Pennsylvania
Prairie Lakes Cancer Center Watertown South Dakota
Tennessee Oncology - Chattanooga Oncology & Hematology Associates Chattanooga Tennessee
Tennessee Cancer Specialists Knoxville Tennessee
Sarah Cannon Research Institute - Tennessee Oncology Nashville Tennessee
MD Anderson Cancer Center Houston Texas
Medical Oncology Associates PS (dba Summit Cancer Centers) Spokane Washington
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

More Beijing InnoCare Pharma Tech Co., Ltd. trials in Poland

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04014205 on ClinicalTrials.gov ↗ ← All trials in Poland