Date: 2015-07-30
Type of information: Initiation of the trial
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: Australia, Belgium, Canada, France, Italy, Republic of Korea, Spain, Taiwan, USA
Trial
details: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body. (NCT02517398)
Latest
news: * On July 30, 2015, a Phase 1 trial sponsored by Merck KGaA was published on the NIH website ClinicalTrials.gov for MSB0011359C (M7824) and is currently recruiting participants.
