Phase 1 Study of Oral EXS73565 for Safety and Effectiveness in Adults with Relapsed or Refractory B-cell Cancers

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes and responds to, and early antitumor effects of EXS73565 taken orally in people with relapsed or refractory B-cell malignancies. This phase 1 study focuses on participants whose disease has returned or worsened after standard treatments or who cannot undergo standard therapies. The types of B-cell cancers included are chronic lymphocytic leukemia, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, and Waldenstroms macroglobulinemia. Participants will receive the experimental drug EXS73565 by mouth as a single agent. The study follows a dose-escalation design to determine the appropriate dose while monitoring safety and drug behavior in the body. Treatment will continue under close observation, with assessments at defined intervals to track effects and side effects. This open-label, multicenter trial does not include placebo or comparison groups. Throughout the study, participants will undergo safety evaluations including monitoring for treatment-emergent adverse events and dose-limiting toxicities up to 282 and 28 days respectively. Researchers will also measure pharmacokinetic parameters like time to maximum concentration and area under the curve up to 253 days. Efficacy outcomes such as overall response rate, progression-free survival, duration and time to response, time to progression, and overall survival will be followed for up to 24 months. Participation involves regular clinical visits, laboratory tests, and assessments to monitor health and treatment effects over the study period.

Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies