Phase 1 Study Evaluating Oral NX-5948 Safety and Activity in Adults with Relapsed or Refractory B-cell Cancers

What this Trial Is About

Researchers are studying NX-5948, an oral drug, in adults with relapsed or refractory B-cell malignancies, including various lymphomas and leukemias such as Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, and others. This Phase 1a1b open-label trial aims to assess the safety, tolerability, and anti-cancer activity of NX-5948 in patients who have received prior treatments and have limited options. The study includes multiple cohorts focusing on different types of B-cell cancers and specific patient characteristics. The study has two main parts Phase 1a dose escalation to determine the maximum tolerated dose and recommended dose for further study, followed by Phase 1b safety expansion and cohort expansion to evaluate the drugs anti-tumor activity at selected doses across various patient groups. Participants receive oral NX-5948 at different dose levels, with some groups randomized to compare doses. The treatment targets a range of B-cell malignancies, including those affecting the central nervous system. Participants are closely monitored throughout the study for dose-limiting toxicities, adverse events, and anti-tumor responses using established criteria. Assessments include measuring overall response rates, pharmacokinetics, pharmacodynamics, and survival outcomes over periods lasting up to several years. The study involves regular visits for safety and efficacy evaluations, and participants organ and bone marrow functions are monitored to ensure suitability for treatment.

A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies