Phase 1 dose-escalation study of BI 836909, an anti-BCMA bi-specific T-cell engager, in relapsed and/or refractory multiple myeloma (RRMM).

TPS8067Background: Myeloma is an incurable disease that typically follows a relapsing course, with many patients (pts) requiring multiple lines of therapy. Outcomes in RRMM remain poor, particularly after failure of proteasome inhibitor (PI)- and/or immunomodulatory drug (IMiD)-based treatment. There remains a need for novel, targeted therapies for RRMM. BI 836909, a bi-specific T-cell engager (BiTE) that binds CD3e on T-cells and BCMA on plasma cells, has demonstrated anti-myeloma activity in preclinical models (Hipp et al. ASH 2015; abs 2999). Here we report the design and objectives of the first in-human trial of BI 836909 – a multicenter, open-label, two-part, Phase 1, dose-escalation study evaluating intravenous (IV) and subcutaneous (SC) formulations of BI 836909 in RRMM. Methods: Adult pts with RRMM after ≥ 2 prior lines of therapy (including a PI and IMiD) and ECOG PS ≤ 2 are eligible. In part A, pts will receive escalating doses (modified 3+3 design) of BI 836909 as a continuous IV infusion for 4...