Tulane Research - Clinical Translational Unit

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

Purpose

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).

Conditions

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part 1 Dose Escalation	Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL	Drug: Orelabrutinib (ICP-022) ICP-022 The drug product is a white, round, uncoated tablet
Experimental Part 2 Dose Expansion	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	Drug: Orelabrutinib (ICP-022) ICP-022 The drug product is a white, round, uncoated tablet

More Details

Status: Active, not recruiting
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.