Phase I safety and pharmacology study of the EpCAM/CD3-bispecific BiTE antibody MT110 in patients with metastatic colorectal, gastric, or lung cancer.

2573^ Background: MT110 is a bispecific antibody construct (BiTE) binding to epithelial cell adhesion molecule (EpCAM) expressed on most solid cancers, and to CD3 on T cells. MT110 has shown remarkable antitumor activity in preclinical solid tumor xenograft models. For non-Hodgkin's lymphoma and ALL the CD19-specific BiTE antibody blinatumomab has proven to be highly effective in phase I and II clinical testing. Methods: This phase I study evaluates safety, tolerability, pharmacokinetics, and antitumor activity of MT110 in patients (pts) with advanced solid tumors widely expressing EpCAM. A dose escalation with 3-6 pts per cohort is used to determine maximum tolerated dose (MTD) and dose- limiting toxicities (DLT). Starting dose was 1 μ g/d given by continuous i.v. infusion for at least one 28-day cycle. Results: As of Jan 2010, a total of 23 pts (4 gastric cancer, 16 CRC, 1 SCLC, 2 NSCLC; age ranging from 45 to 85 years, 65% of pts with at least 3 lines of previous chemotherapies) have been treated with ...