Phase 1 Study to Assess Safety and Effectiveness of Oral GLB-002 in Adults With Relapsed or Refractory Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating GLB-002, an oral drug, in adults with relapsed or refractory Non-Hodgkin lymphomas NHL to assess its safety, how the body processes it, its effects on the body, and early signs of effectiveness. This first-in-human, open-label, phase 1 study includes participants who have not responded to standard treatments or lack effective options. The study is sponsored by Hangzhou GluBio Pharmaceutical Co., Ltd. and aims to identify appropriate dosing and tolerability in this patient population. The study has two main parts. Part 1a involves dose escalation to find the maximum tolerated dose and recommended doses by gradually increasing the dose in participants with relapsed or refractory NHL. Part 1b includes three dose expansion cohorts to confirm tolerability and evaluate efficacy in specific NHL subtypes follicular lymphoma Grade 1, 2, 3a, diffuse large B-cell lymphoma and follicular lymphoma Grade 3b, and other NHL types such as mantle-cell lymphoma, marginal zone lymphoma, small lymphocytic lymphomachronic lymphocytic leukemia, and peripheral T-cell lymphoma. GLB-002 is taken orally following assigned schedules, and dosing can continue for up to two years. Participants will have regular assessments including monitoring for dose-limiting toxicities within 35 days of the first dose, adverse events, and response to treatment over up to two years. Pharmacokinetic studies of GLB-002 and its related compounds will be performed after single and multiple doses. Outcome measures include objective response rate, time to response, duration of response, progression-free survival, and overall survival. Safety is closely monitored through adverse event reporting and clinical evaluations throughout the treatment period.

A Study of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas