Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.
Trial Parameters
Brief Summary
This is a phase I, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and clinical activity of LP-168 in subjects with relapsed or refractory B-cell malignancies. LP-168 is a small molecule inhibitor.
Eligibility Criteria
Inclusion Criteria: A subject will be eligible for study participation if he/she meets the following criteria: * Subjects are eligible with B-cell malignancies, WM, FL, MCL, MZL, DLBCL, HCL, CLL, SLL, based upon 2016 updated WHO classification. Those subjects with WM, FL, MCL, DLBCL, or HCL must have received at least 2 prior systemic therapies. * Low-grade B-cell lymphomas as follicular Grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma. * Subject must have adequate coagulation, renal, and hepatic function, per local laboratory reference ranges at Screening as follows: * Activated partial thromboplastin time (APTT) and prothrombin time (PT) not to exceed 1.5 × ULN * Calculated creatinine clearance (CrCl) ≥ 60 mL/min using 24-hour CrCl OR Cockcroft-Gault formula. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 ×ULN; Bilirubin ≤ 1.5 × ULN (except subjects with Gilbert's Syndrome, who may have a bilirubin \> 1.5 × ULN, per discussion between the In