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

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 1

Conditions: Mature B Cell Neoplasms

Treatments: Drug: SHR1459

Study type: Interventional

Funder types: Industry

Identifiers

NCT03664297

SHR1459-I-101

Details and patient eligibility

About

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.

Full 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);

Enrollment: 86 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

86 participants in 1 patient group

SHR1459

Experimental group

Description:

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

Treatment:

Drug: SHR1459