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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Part 1：r/r B-cell Malignancies, Part 2：B-cell Malignancies

In brief

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).

Key facts

Study ID

NCT04014205

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

81

Starts

2019-11-18

Expected to finish

2026-06-30

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent.
• Age ≥ 18 years.
• 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.
• Life expectancy (in the opinion of the investigator) of ≥ 4 months.
• ECOG performance status of 0 \~1.
• Must have adequate organ function.
• Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection

You may not qualify if…

• Pregnant or breast-feeding or intending to become pregnant during the study.
• Prior treatment with systemic immunotherapeutic agents.
• Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
• Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
• History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
• Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
• Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
• Active uncontrolled infections.
• Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
• Unresolved toxicities from prior anti-cancer therapy.
• Medically apparent CNS lymphoma or leptomeningeal disease.
• Current or previous history of CNS disease.
• Major surgery or significant traumatic injury < 28 days prior to the first dose of the study drug.
• Patients with another invasive malignancy in the last 2 years.
• Significant cardiovascular disease or active pulmonary disease.
• Received systemic immunosuppressive medications.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.