Phase 1 Study Evaluating Safety and Treatment Effects of Oral NX-2127 in Adults with Relapsed or Resistant B-cell Cancers

What this Trial Is About

Researchers are evaluating NX-2127, an oral drug, in adults with relapsed or refractory B-cell malignancies. This first-in-human Phase 1a1b open-label study aims to assess the safety, tolerability, and anti-cancer activity of NX-2127 in patients who have had multiple prior treatments and for whom no other therapies are known to provide benefit. The study includes various types of B-cell cancers such as chronic lymphocytic leukemia, mantle cell lymphoma, follicular lymphoma, and others. The study consists of two parts Phase 1a focuses on dose escalation to find the maximum tolerated dose and the recommended dose for Phase 1b. Phase 1b uses a two-stage design to further evaluate safety, tolerability, and preliminary efficacy at selected doses. Stage 1 enrolls about 10 participants per disease group for initial evaluation, while Stage 2 enrolls additional participants randomized to one of two dose levels. Participants receive multiple dose levels of NX-2127 orally, tailored to their specific type of B-cell malignancy and prior treatment history. Participants will be closely monitored for dose-limiting toxicities, adverse events, and clinical laboratory abnormalities for up to five years. Researchers will assess overall response rates, duration of response, progression-free survival, and overall survival as measures of clinical activity. Safety and tolerability data will be collected throughout the study. The study involves regular evaluations, including physical exams, laboratory tests, and disease response assessments, to track participants health and treatment effects over time.

A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies