Phase 1b Study of Oral Docirbrutinib for Patients With Previously Treated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating oral AS-1763 docirbrutinib in patients with chronic lymphocytic leukemia CLL, small lymphocytic lymphoma SLL, or B-cell non-Hodgkin lymphoma NHL who have not responded to or cannot tolerate at least two previous treatments. This Phase 1b, open-label, multi-center study aims to assess the safety, tolerance, and preliminary effectiveness of docirbrutinib in these patients. The study has two parts dose escalation and dose expansion. In dose escalation, up to 27 patients will receive increasing doses of docirbrutinib tablets taken twice daily starting at 100 mg to find the maximum tolerated dose MTD. The dose expansion part will enroll up to 48 CLLSLL patients, 35 NHL patients, and 10 patients previously treated with a similar drug, pirtobrutinib. Patients will take docirbrutinib oral tablets twice daily for up to 24 cycles, each cycle lasting 28 days, with dose levels determined from the dose escalation results. Participants will be monitored throughout treatment for safety and response, including evaluations of side effects and blood tests. Assessments will continue for 24 cycles or until disease progression or unacceptable side effects. After treatment, patients will be followed for survival for up to two years. Researchers will measure dose-limiting toxicities, maximum tolerated dose, overall response rate, and other outcomes related to drug levels and disease status.

AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma