A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    80
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 28 February 2022

Summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 80 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

Details
Condition MZL
Treatment ICP-022
Clinical Study IdentifierNCT03797456
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on28 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women between 18 and 75 years old
Histologically confirmed marginal zone lymphoma (MZL), and at least one measurable tumor of greater than 1.5 centimeter outside of the spleen
Subjects with refractory or relapsed MZL who has received at least 1 but no more than 4 prior therapies for MZL
ECOG performance status of 0-2
Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen
Subjects who have indications for treatment (threatened end-organ function, bulky disease >5cm, symptoms, steady progression, wish to treat)
Subjects meet the following laboratory parameters
Absolute neutrophil count (ANC) 1.5109/L Platelet count 75109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin 75 g/L; ANC 1.0109/L, Platelet count 50109/L, Hemoglobin 50 g/L; if bone marrow involvement
Total bilirubin 1.5 ULN; AST or ALT 2 ULN; Creatinine 1.5 ULN; Amylase ULN and Lipase ULN
International normalized ratio (INR) 1.5 ULN
Life expectancy 3 months
Able to provide signed written informed consent

Exclusion Criteria

History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
Current or history of lymphoma involved central nervous system
Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody-based therapies or anti-cancer TCM within 4 weeks of the start of study drug
Non-hematological toxicity must recover to Grade 1 from prior anti-cancer therapy (except for alopecia)
Current clinically significant cardiovascular disease including
Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%
Primary cardiomyopathy
Clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male)
Uncontrolled hypertension
Known active bleeding within 2 months of screening or currently taking anticoagulant/antiplatelet drugs
Urine protein 2+ and quantitation 2g/24hours
History of deep vein thrombosis or pulmonary embolism
Toxicity must be recovered to Grade 1 from prior anti-cancer therapy
Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach
Prior organ or hematopoietic stem cell transplant
Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup
Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection
Any history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment
Prior exposure to a BTK or BCR pathway inhibitor (PI3K or Syk) and BCL-2 inhibitor
Suitable and ready for allogeneic stem cell transplant
Inability to comply with study procedures
Drug abuser or alcoholics
Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children
Requires treatment with moderate or strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
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