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Clinical trial

Phase 1 Study to Evaluate the Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrentreplased/Refractory Mature B Cell Neoplasms Tumor

ID
Name
SHR1459-I-101
Description
SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor.
Trial arms
Trial start
2018-02-06
Estimated PCD
2023-12-30
Trial end
2024-12-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
SHR1459
SHR1459 will be administered continually till disease progression or unacceptable toxicity.
Arms:
SHR1459
Other names:
No other intervention
Size
86
Primary endpoint
Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability])
through study completion, an average of about 6 months
Recommended phase 2 dose (RP2D)
28 days since the date of first dose
Eligibility criteria
Inclusion Criteria: * ECOG Performance Status \[PS\] score must be 0 or 1; * Life expectancy ≥ 12 weeks; * Mature B cell eoplasmss with histological or cytological diagnosis, including diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) , chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) and waldenstrom macroglobulinemia (WM); * The function of bone marrow is basically normal; * Renal function is basically normal; * Hepatic function is basically normal. Exclusion Criteria: * Had received treatment with the compound of the same mechanism (BTK inhibitor); * With infiltration of lymphoma central nervous system; * Received autologous stem cell transplantation within 60 days before signing the informed consent, received allogeneic stem cell transplantation in 90 days (after allogeneic stem cell transplantation, if graft-versus-host disease appeared, it must be ≤ level 1, and if there was no prohibited medication, the screening could be performed);
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 86, 'type': 'ACTUAL'}}
Updated at
2022-11-14

1 organization

1 product

1 indication

Organization
Jiangsu HengRui Medicine
Product
SHR1459
Indication
Mature B Cell Neoplasms