ArQule said Tuesday it has begun dosing patients in a phase 1a/b trial with its BTK inhibitor, ARQ 531, in patients with B-cell malignancies refractory to other approved therapies. The trial is designed to enroll patients with B-cell malignancies including B-cell lymphomas, chronic lymphocytic leukemia, and Waldenstrom’s macroglobulinemia. The phase 1a portion of the trial will be a dose escalation study open to all refractory patients, with the aim of establishing a recommended dose.
Upon completion of the phase 1a trial, the company plans to begin the phase 1b portion of trial that will consist of a number of expansion cohorts including patients with the C481S. The goal of the phase 1b portion would be to establish proof of concept and early signs of activity.