A Phase 1 / 2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL / SLL) or Non-Hodgkin's Lymphoma (NHL)
18 Years and older, Male and Female
This is an open-label, multi-center Phase 1 / 2 study of oral LOXO-305 in patients with CLL / SLL and NHL who have failed or are intolerant to standard of care.
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients will be enrolled using an accelerated titration design. The starting dose of LOXO-305 in oral tablet form is 25 mg/day (e.g., 25 mg once daily [QD]). Once the MTD and/or RP2D is identified, patients will be enrolled to one of six phase 2 dose expansion cohorts depending on tumor histology, tumor genotype, and prior treatment history. Cycle length will be 28 days.