Elaboration of a Phase II clinical study protocol for the treatment of metastatic non-small cell lung cancer (NSCLC) using AB-16B5, an epithelial to mesenchymal transition (EMT) inhibitor, in combination with docetaxel
The molecular mechanisms responsible for the occurrence of metastatic cancer are beginning to be elucidated with the identification of key regulators. Increasing evidence points to tumor cell epithelial to mesenchymal transition (EMT) as an important contributing process to metastatic evolution. The identification of factors that are stimulated during EMT might provide the means to develop new drugs required to increase the effectiveness of current regimens and improve patient outcome. Alethia Biotherapeutics is developing its AB-16B5, a humanized monoclonal antibody that targets secreted clusterin, a protein that is stimulated during EMT and contributes to invasion of tumors cells. The treatment with a true inhibitor of EMT is predicted to increase the effectiveness of current therapy and decrease metastasis, which should result in improved patient survival. Alethia Biotherapeutics has recently completed a first-in-human Phase I study with AB-16B5 in patients with advanced carcinomas. The primary objective of the proposed project is to elaborate a Phase II clinical trial protocol to test the hypothesis that treatment with AB-16B5 in combination with docetaxel, a cytotoxic agent, will result in an increased response rate.