Status:
UNKNOWN
A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Part 1：r/r B-cell Malignancies
Part 2：B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 malig...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04014205
Start Date
November 18 2019
End Date
January 30 2025
Last Update
April 18 2023
Active Locations (36)
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1
Mayo Clinic-Mayo Clinic Hospital-Phoenix
Phoenix, Arizona, United States, 85054-4502
2
Pacific Cancer Medical Center
Anaheim, California, United States, 92801-1824
3
Los Angeles Cancer Network - Good Samaritan Hospital Location
Los Angeles, California, United States, 90017
4
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270