The FDA has authorized the initiation of a phase I clinical trial with MVT-1075 as a therapeutic treatment for pancreatic cancer. MVT-1075 (177Lu-CHX-A"-DTPA-HuMab5B1) is a novel, fully human antibody radioimmunotherapy (RIT). The trial will be initiated among patients with recurrent pancreatic cancer and other CA19-9 positive malignancies in the first half of 2017.
The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.
In this initial phase I trial, the safety, dosimetry, and pharmacokinetics of MVT-1075 will be evaluated. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria.