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

  • STATUS
    Recruiting
  • End date
    Jul 3, 2023
  • participants needed
    15
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
Updated on 28 January 2021
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, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of a novel BTK inhibitor, ICP-022. During this study, dose escalation will be conducted in patients diagnosed with refractory/relapsed (r/r) B-cell malignancies including only patients with Grades1-3a follicular lymphoma (FL); marginal zone lymphoma (MZL); mantle cell lymphoma (MCL); and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Details
Condition Follicular Lymphoma, Lymphoma, MALT Lymphoma, Mantle cell lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, b-cell small lymphocytic lymphoma
Treatment ICP-022
Clinical Study IdentifierNCT04014205
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic Lymphocytic Leukemia or Lymphocytic Leukemia, Chronic or MALT Lymphoma or Lymphoma or Mantle cell lymphoma or Marginal Zone Lymphoma or Non-Ho...?
Do you have any of these conditions: Lymphoma or MALT Lymphoma or leukemia chronic lymphocytic or b-cell small lymphocytic lymphoma or Chronic Lymphocytic Leukemia or Follicular Lymphoma ...?
Do you have any of these conditions: MALT Lymphoma or Non-Hodgkin's Lymphoma or small lymphocytic lymphoma or b-cell small lymphocytic lymphoma or Follicular Lymphoma or Mantle cell lymph...?
Do you have any of these conditions: Lymphocytic Leukemia, Chronic or chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma or b-cell small lymphocytic lymphoma or Follicular L...?
Signed Informed Consent
All subjects must meet criteria for requiring therapy at time of enrollment (see treatment indications below)
Age 18 years
Patients with histologically confirmed relapsed or refractory B-cell malignancies, including only patients with Grades 1-3a FL, MZL, MCL, and CLL/SLL
Patient must had received 1 or 4 prior therapies with documented failure to achieve at least partial response, or disease progression after the most recent systemic treatment
Patient must have 1 measurable lesion site on CT scan (>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead (Subjects with spleen-only disease are considered as not having measurable disease)
Electrocorticogram(ECOG) performance status of 0 ~1
Life expectancy (in the opinion of the investigator) of 4 months
Adequate liver function at time of screening: Total bilirubin 2.0 x Upper Limit of Normal (ULN) (Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible); Aspartate aminotransferase(AST)/ Alanine Aminotransferase(ALT) 2.5 ULN
Coagulation test: at time of screening, international normalized ratio (INR) 1.5, and the activated partial thromboplastin time (APTT) 1.5 ULN
Adequate hematological function at time of screening: complete blood count tests should be independent of support therapies (i.e., growth factors, or transfusion) and fulfill these criteria: neutrophil count 1.5 109 /L, platelet count 75 109/L, hemoglobin 80 g/L; if presence of bone marrow infiltration, neutrophil count 1.0 109 /L and platelet count 50 109 /L
Adequate renal function at time of screening: serum creatinine 1.5 ULN or creatinine clearance by Cockcroft-Gault formula 60 mL/min
Negative test results for Hepatitis B Virus(HBV) ([HBsAg (-)] and non-active HBV or Hepatitis C Virus(HCV) infection
Patients who are positive for anti-Hepatitis B Virus core(anti-HBc) antibody must be negative for HBV DNA by Polymerase Chain Reaction (PCR) to be eligible for study participation
Patients who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation
Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential and who are considered to be postmenopausal ( 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test
Patients must agree to either remain completely abstinent or to use two effective contraceptive methods that result in a failure rate of <1 % per year from screening until (a) 1 month if the patient is a male or (b) 2 months if patient is a female after the last dose of Innocare Pharma-022(ICP-022)

Exclusion Criteria

Pregnant or breast-feeding or intending to become pregnant during the study
Prior treatment with systemic immunotherapeutic agents, including but not limited to cytokine therapy and anti-CTLA4, anti-Programmed death 1(anti-PD1) and antiProgrammed cell death 1 ligand 1(anti-PDL1) therapeutic antibodies, within 12 weeks or five half-lives of the drug, whichever is shorter, before first dose of ICP-022
Treatment with any Bruton's tyrosine kinase inhibitor(BTKi), phosphatidylinositol 3 kinase( PI3Ki) or B-cell lymphoma-2(BCL-2) inhibitor
Patients with known allergies to ICP-022 or its excipients
Treatment with any chemotherapeutic agent, or treatment with any other investigational therapies including but not limited to anti-cancer agent (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks prior to first dose of ICP-022
History of allogeneic stem-cell (or other organ) transplantation
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
Concurrent use of a strong Cytochrome P450 3A (CYP3A) inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half-lives of the prohibited medication
Active uncontrolled infections
Recent infection requiring IV anti-infective treatment that was completed 14 days before the first dose of study drug
Known infection with HIV, seropositive status
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) Grade 1, or to the levels dictated in the eligibility criteria with the exception of alopecia
Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
Medically apparent central nervous system(CNS) lymphoma or leptomeningeal disease
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Patients with a history of stroke who have not experienced a stroke or
transient ischemic attack in the past 2 years and have no residual neurologic
deficits as judged by the investigator, are allowed
\. Evidence of significant, uncontrolled concomitant diseases that could
affect compliance with the protocol or interpretation of results, including
diabetes mellitus, history of relevant pulmonary disorders, abusing of alcohol
or illegal drugs including non-prescribed marijuana within last 6 months from
screening
\. Major surgery or significant traumatic injury < 28 days prior to the
first dose of ICP-022 (excluding biopsies) or anticipation of the need for
major surgery during study treatment
\. Patients with another invasive malignancy in the last 2 years (with the
exception of basal cell carcinoma and tumors deemed by the investigator to be
of low likelihood for recurrence)
\. Significant cardiovascular disease such as New York Heart Association
(NYHA) Class III or IV cardiac disease, myocardial infarction within the last
months, unstable arrhythmias, or unstable angina)
\. Significant active pulmonary disease (e.g., bronchospasm and/or
obstructive pulmonary disease)
\. Administration of a live, attenuated vaccine within 28 days before Cycle
Day 1 or anticipation that such a live attenuated vaccine will be required
during the study
\. Received systemic immunosuppressive medications (including but not
limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti-tumor necrosis factor agents) with the exception of corticosteroid
treatment < 20 mg/day prednisone or equivalent within 7 days prior to first
dose of ICP-022
Inhaled and topical steroids are permitted
\. Unable to swallow tablets or disease significantly affecting
gastrointestinal function such as malabsorption syndrome, resection of the
stomach or small bowel, symptomatic inflammatory bowel disease, or partial or
complete bowel obstruction
\. Any other diseases, metabolic dysfunction, physical examination finding
or clinical laboratory finding giving reasonable suspicion of a disease or
condition that would contraindicate the use of an investigational drug
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