A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
- Conditions
- Part 2：B-cell MalignanciesPart 1：r/r B-cell Malignancies
- Interventions
- Registration Number
- NCT04014205
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 81
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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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 Dose Expansion Orelabrutinib (ICP-022) Arm 1: Patients with r/r MCL Arm 2: Patients with other types of B-cell malignancies, including: * CLL/SLL with/without prior treatment * r/r FL * r/r MZL Part 1 Dose Escalation Orelabrutinib (ICP-022) Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Part 1 Dose Escalation：T1/2 Up to 2 years Elimination half-life
Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability] Up to 2 years The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Part 1 Dose Escalation：ORR Up to 2 years Objective response rate
Part 2 Dose Expansion：DOR Up to 2 years Duration of response
Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability] Up to 2 years The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of ICP-022 will be assessed
Trial Locations
- Locations (36)
Los Angeles Cancer Network - Good Samaritan Hospital Location
🇺🇸Los Angeles, California, United States
Desert Hematology Oncology Medical Group, Inc.
🇺🇸Rancho Mirage, California, United States
University of Pittsburgh - Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)
🇺🇸Topeka, Kansas, United States
Mayo Clinic-Mayo Clinic Hospital-Phoenix
🇺🇸Phoenix, Arizona, United States
The Oncology Institute of Hope & Innovation
🇺🇸Whittier, California, United States
Pacific Cancer Medical Center
🇺🇸Anaheim, California, United States
Florida Cancer Specialists (FCS) South
🇺🇸Fort Myers, Florida, United States
Asclepes Research Centers - Weeki Wachee
🇺🇸Weeki Wachee, Florida, United States
Orchard Healthcare Research Inc.
🇺🇸Skokie, Illinois, United States
Goshen Center for Cancer Care
🇺🇸Goshen, Indiana, 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
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Summit Medical Group
🇺🇸Florham Park, New Jersey, United States
Mayo Clinic - Minnesota
🇺🇸Rochester, Minnesota, United States
Southeast Nebraska Cancer Center
🇺🇸Lincoln, Nebraska, United States
Gabrail Cancer Research Center
🇺🇸Canton, Ohio, United States
Clinical Research Alliance
🇺🇸Westbury, New York, United States
Guthrie Cancer Center
🇺🇸Sayre, Pennsylvania, United States
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Prairie Lakes Cancer Center
🇺🇸Watertown, South Dakota, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Sarah Cannon Research Institute - Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Medical Oncology Associates PS (dba Summit Cancer Centers)
🇺🇸Spokane, Washington, United States
Carmel Medical Center
🇮🇱Haifa, Israel
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Institute of Blood Pathology and Transfusion Medicine
🇺🇦Lviv, Ukraine
Cherkassy Regional Oncology Center
🇺🇦Cherkasy, Ukraine
St. Luke's Hospital - Medical and Diagnostic Center
🇺🇦Kropyvnytskyi, Ukraine
Khmelnytskyi Regional Hospital
🇺🇦Khmelnytskyi, Ukraine
National Cancer Institute
🇺🇦Kyiv, Ukraine
Transcarpathian Regional Clinical Hospital named after Andrii Novak
🇺🇦Uzhgorod, Ukraine
Northwest Neurology - Rolling Meadows Office
🇺🇸Elk Grove Village, Illinois, United States