Date: 2016-03-01
Type of information: Initiation of preclinical development
phase: 1
Announcement: initiation of the trial
Company: Merck KGaA (Germany)
Product: MSB0011359C (M7824)
Action
mechanism: fusion protein/monoclonal antibody/immune checkpoint inhibitor. MSB0011359C (M7824) is a bifunctional fusion protein composed of avelumab, an anti-programmed death ligand 1 (PD-L1) human monoclonal antibody bound to the soluble extracellular domain of human transforming growth factor beta (TGFbeta) receptor type II (TGFbetaRII), with potential antineoplastic and immune checkpoint modulating activities. Upon administration, the TGFbetaRII moiety of MSB0011359C binds to and neutralizes TGFbeta while the avelumab moiety simultaneously binds to PD-L1. This prevents TGFbeta- and PD-L1-mediated signaling, and increases natural killer (NK) cell and cytotoxic T-lymphocyte (CTL) activities. This inhibits tumor cell proliferation in susceptible tumor cells.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country: Germany
Trial
details: The main purpose of this study is assess the safety and tolerability of MSB0011359C. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or a standard therapy has failed. (NCT02699515)
Latest
news: * On March 1, 2016, a Phase 1 trial sponsored by Merck KGaA was published on the NIH website ClinicalTrials.gov for MSB0011359C (M7824) and is currently recruiting participants.
