A phase I/IIA safety study of NPC-1C: A novel, therapeutic antibody to treat pancreas and colorectal cancers.

233 Background: NPC-1C (NEO-101; ensituximab) is a chimeric monoclonal antibody being developed as a novel biological treatment for pancreatic and colorectal cancers. This antibody was selected from a panel of hybridomas generated from mice immunized with semi-purified membrane-associated proteins derived from biologically screened, pooled human allogeneic colon cancer tissues. The NPC-1C target appears to be a variant of MUC5AC that is expressed specifically by human colon and pancreatic tumors with only occasional minimal cross-reactivity to certain GI tract tissues. Methods: A Phase 1/2A open label, multi-center dose escalation clinical trial with NPC-1C is currently accruing subjects with advanced pancreatic and colorectal cancer who are refractory to standard therapy. The primary objectives of the Phase I clinical trial are to determine the safety and tolerability of escalating doses of NPC-1C and to assess pharmacokinetics (PK) and select immune responses to the antibody at each dose level. Secondar...