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FPI-2053 is a humanized bispecific monoclonal antibody that targets both the epidermal growth factor receptor (EGFR) and the hepatocyte growth factor receptor (HGFR, also known as c-Met). It is being developed as a ligand for radiotherapy and diagnostic imaging in oncology. The drug serves as the targeting component of radiopharmaceutical conjugates such as [225Ac]-FPI-2068, which links FPI-2053 to the alpha-emitting radioisotope actinium-225 for targeted radiotherapy. Its mechanism involves simultaneous binding to EGFR and c-Met on tumor cells, potentially enhancing specificity and efficacy in treating advanced solid tumors. The primary developer is Fusion Pharmaceuticals. Clinical development is ongoing for various advanced solid tumors including head and neck squamous cell carcinoma, non-small-cell lung cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, adenocarcinoma, squamous cell carcinoma, and pancreatic cancer.
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