NEW YORK – Perspective Therapeutics said on Wednesday that it has treated the first patient in a clinical trial of its targeted alpha therapy radiopharmaceutical, 212Pb-VMT-α-NET, for advanced, somatostatin receptor type 2 (SSTR2)-positive neuroendocrine tumors.
Through the Phase I/IIb clinical trial, Perspective is evaluating the SSTR2-directed radiopharmaceutical as a treatment for advanced neuroendocrine tumor patients who have not previously received peptide receptor radionuclide therapy and whose cancers express SSTR2 as determined by a US Food and Drug Administration-approved, gallium-68- or copper-64-based SSTR PET imaging agent.
During the first part of the study, Perspective aims to determine the maximum tolerated dose or maximum feasible dose of 212Pb-VMT-α-NET. In the second part of the study, the firm will study the determined maximum dose, looking at patients' overall response rates, durations of response, and progression-free survival, among other endpoints.
According to a statement from Perspective CEO Thijs Spoor, the firm believes that 212Pb-VMT-α-NET has "the potential to provide significant improvements in clinical outcomes" compared to Novartis' NET radiopharmaceutical, Lutathera (177Lu-dotatate).
The radiopharmaceutical has received fast-track designation from the FDA for NETS, and Spoor said, "We plan to rapidly advance this product through clinical development."
The firm hopes to present preliminary findings from the ongoing trial in early 2024.
In August, Perspective — which used to be named Viewpoint Molecular Targeting — announced it has also started studying its targeted alpha therapy in (MC1R)-expressing advanced melanoma.