The open label clinical trial is composed of two parts: a Phase I dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TRU-016; and a Phase II expansion cohort designed to further evaluate safety and to estimate clinical activity of TRU- 016 in patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia. Trubion currently retains all development and commercialization rights for the TRU-016 program.
This Phase I/II clinical trial is designed to enroll patients who have undergone at least one prior therapy and have relapsed CLL or small lymphocytic leukemia. Efficacy will be evaluated according to disease response and progression status per the International Response Criteria for CLL. Participants will receive intravenous administration of TRU-016 over a four- week period.
Peter Thompson, president, CEO and chairman of Trubion, said: “This is an important milestone for our proprietary program and we look forward to the results of TRU-016’s ongoing clinical evaluation. Our proprietary product candidate, TRU-016, has demonstrated potent antitumor activity in preclinical evaluation and may provide patients with improved therapeutic options or benefits when used alone or in conjunction with chemotherapy or CD20-targeted immunopharmaceuticals.”