Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the first patient has been dosed in the multi-dose portion of the Phase 1 study evaluating [225Ac]-FPI-1434 (FPI-1434) in patients with advanced solid tumors. FPI-1434 is a radioimmunoconjugate that utilizes Fusion's proprietary Fast-Clear™ linker to connect a humanized monoclonal antibody targeting the insulin-like growth factor 1 receptor (IGF-1R), with the alpha-emitting isotope actinium-225, creating a targeted alpha therapy (TAT).
The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability and pharmacokinetics of FPI-1434 in patients with solid tumors expressing IGF-1R. The trial is also designed to establish the maximum tolerated dose for FPI-1434 and the recommended Phase 2 dose. As part of the precision medicine approach, prior to receiving the therapeutic injection of FPI-1434, patients are administered an indium-111 imaging analogue, [111In]-FPI-1547 (FPI-1547). The images collected are used to confirm the presence of tumor uptake and to ensure that estimated radiation doses to organs and tissues are below protocol-specified safety limits.
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