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

NCT ID: NCT03664297

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2024-12-30

Brief Summary

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.

Detailed 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. 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);

Conditions

Mature B Cell Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR1459

Oral administration, once a day, 28 days for a cycle, until the disease progression or the intolerable toxicity occurs.

Group Type: EXPERIMENTAL

SHR1459

Intervention Type: DRUG

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

Interventions

SHR1459

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

Intervention Type: DRUG

Other Intervention Names

No other intervention

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lugui Qiu

Role: PRINCIPAL_INVESTIGATOR

Blood Institute of the Chinese Academy of Medical Sciences

Locations

Blood disease hospital of Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

SHR1459-I-101

Identifier Type: -

Identifier Source: org_study_id