Phase 1 Study of Oral LP-168 for Adults With Relapsed or Refractory B-Cell Lymphoma Evaluating Safety and Preliminary Effectiveness

What this Trial Is About

Researchers are evaluating LP-168, an oral drug, in adults with relapse or refractory B-cell lymphoma, including chronic lymphocytic leukemiasmall lymphocytic lymphoma CLLSLL and non-Hodgkins lymphoma NHL. This open-label, multi-center Phase 1 study aims to find the maximum tolerated dose and recommended dose for further study while assessing safety, tolerability, and early antitumor activity. The study has two parts Phase 1a involves dose escalation of LP-168 tablets starting at 100 mg once daily, using a 33 design to identify the best dose. Phase 1b expands enrollment to more patients at the recommended dose. Treatment cycles last 28 days, and participants take LP-168 orally once or twice daily with water, without food. Participants will be monitored for up to 24 months for safety, response to treatment, and drug levels in the blood. Assessments include tracking adverse events, tumor response, progression-free survival, and pharmacokinetics such as drug concentration over time. The study involves blood tests, biopsies, and other exams to understand how LP-168 works and its effects on lymphoma.

A Study of LP-168 in Participants With Relapse or Refractory B-Cell Lymphoma