This clinical trial is for men and women age 18 and older with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This is a combined Phase 1/2 study of oral TP-0903 in patients with previously treated CLL/SLL to characterize the safety and toxicity profile of TP-0903 and to determine the recommended phase 2 dose. In both Phase 1 and Phase 2, study participants will be assigned to one of two defined patient groups: Monotherapy and combination therapy. Both groups of patients will be treated identically with TP-0903 and will undergo the same study assessments.
Group 1 (TP-0903 monotherapy): Patients with CLL/SLL who are intolerant to, or have progressed on, B-cell receptor antagonists and/or BCL-2 antagonists
Group 2 (TP-0903 and ibrutinib combination therapy): Patients with CLL/SLL who have progressed on ibrutinib yet the treating provider considers continuation of ibrutinib therapy to be in the best interest of the patie
TP-0903 is an oral inhibitor that targets and binds to AXL kinase and prevents tumor cell proliferation. TP-0903 will be administered orally once daily for 28 days. Participants will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.