Phase I Study to Evaluate Oral LP-168 Safety, Dosing, and Effects in Adults With Relapsed or Refractory B-cell Malignancies

What this Trial Is About

Researchers are evaluating LP-168, a small molecule inhibitor, in adults with relapsed or refractory B-cell malignancies such as CLLSLL, Waldenstrom Macroglobulinemia, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Diffuse Large B Cell Lymphoma, and Hairy Cell Leukemia. This phase I, multi-center, open-label study aims to assess the safety, tolerability, pharmacokinetics, and clinical activity of LP-168 in this patient population. The study also seeks to define the maximum tolerated dose and recommended dose for further research. Participants receive LP-168 orally either once or twice daily in escalating doses starting at 100 mg per day in cohorts of three to six subjects, with each treatment cycle lasting 28 days. After finding the maximum tolerated dose and recommended Phase 2 dose, additional subjects will join an expansion phase to further explore safety, tolerability, pharmacokinetics, and preliminary efficacy. The dose levels range up to 1000 mg once daily, with treatment continuing up to 24 months. During the study, participants will undergo regular assessments including safety evaluations, blood tests for pharmacokinetics at multiple specified days within treatment cycles, and monitoring of response to treatment. Researchers will measure maximum tolerated dose, pharmacokinetic profiles, progression-free survival, objective response rate, and duration of response. The study involves continuous monitoring for up to 24 months, with cycles of 28 days each, to evaluate the effects and safety of LP-168.

Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B-cell Malignancies.