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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    81
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 28 February 2022
ct scan
platelet count
cancer
lymphoid leukemia
chronic lymphocytic leukemia
tyrosine
lymphoma
measurable disease
growth factor
leukemia
lymphocytic leukemia
gilbert's syndrome
hepatitis b surface antigen
neutrophil count
blood transfusion
follicular lymphoma
mantle cell lymphoma
marginal zone lymphoma
renal function tests
btk inhibitor
hepatitis b core antibody
bone marrow infiltration

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).

Details
Condition Part 1:r/r B-cell Malignancies, Part 2:B-cell Malignancies
Treatment ICP-022, Orelabrutinib (ICP-022)
Clinical Study IdentifierNCT04014205
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor
Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug
Pregnant or breast-feeding or intending to become pregnant during the study
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
Any external beam radiation therapy within 6 weeks 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
Active uncontrolled infections
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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