Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor

Jiangsu HengRui Medicine Co., Ltd.86 enrolled

Overview

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. The objective of this phase 1 study is to evaluate the safety and tolerance of SHR1459 in patients with replaced/refractory mature B cell neoplasms, in order to determine the maximum tolerated dose (MTD) and recommended dose for phase 2 clinical study (RP2D);

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mature B Cell Neoplasms

Interventions

SHR1459DRUG

SHR1459 will be administered continually till disease progression or unacceptable toxicity.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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);

Locations (1)

Blood disease hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability])

The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR1459 will be assessed

Time frame: through study completion, an average of about 6 months

Recommended phase 2 dose (RP2D)

Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of SHR1459

Time frame: 28 days since the date of first dose

Secondary Outcomes

Objective response rate (ORR)

Assess the response rate of subjects to the treatment of SHR1459

Time frame: every 8 weeks through study completion, an average of about 6 months

Duration of Response (DoR)

Assess the duration of complete/partial response after the treatment of SHR1459

Time frame: every 8 weeks through study completion, an average of about 6 months

Progression-free survival (PFS)

Assess the survival condition of the subjects after the treatment of SHR1459

Time frame: every 8 weeks through study completion, an average of about 6 months

Time to Response (TTR)

Assess time to response of SHR 1459 after treatment

Time frame: every 8 weeks through study completion, an average of about 6 months

Time to peak (Tmax)

Pharmacokinetics profile of a single dose SHR1459 and its metabolite (plasma): Time to peak (Tmax) of plasma concentration

Data from ClinicalTrials.gov

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