Date: 2011-09-01
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the study
Company: Bayer (Germany)
Product: maytansinoid-conjugated human monoclonal antibody against mesothelin (BAY 94-9343 - antibody drug conjugate ADC))
Action
mechanism: Mesothelin is overexpressed on all mesotheliomas as well as many ovarian and pancreatic cancers while minimally expressed on normal tissue. BAY 94-9343 is an anti-mesothelin antibody-drug conjugate consisting of a fully human monoclonal antibody directed against mesothelin conjugated with the maytansinoid derivative DM4 by a linker containing a disulfide bridge (SPDB). The monoclonal antibody moiety of this conjugate targets and binds to the tumor associated antigen mesothelin; upon internalization, the DM4 moiety binds to tubulin and disrupts microtubule assembly/disassembly dynamics, resulting in inhibition of cell division and cell growth of mesothelin-expressing tumor cells.
Disease: advanced solid tumors
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: This study is an open label phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and maximmum tolerated dose of BAY94-9343 in patients with advanced solid tumors. This study is currently recruiting participants.
BAY94-9343 will be administered intravenously in this study. The starting dose for this first-in-man study is 0.15 mg/kg administered as a 1 hour infusion every 21 days.
