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Perspective Therapeutics Treats First Patient in Second Cohort Of [212Pb]PSV359 Cancer Trial

Perspective Therapeutics begins dosing second cohort in Phase 1/2a trial of [212Pb]PSV359 for FAP-α–expressing solid tumors.

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  • Oct 03, 2025

  • Vaibhavi M.

Perspective Therapeutics Treats First Patient in Second Cohort Of [212Pb]PSV359 Cancer Trial

Perspective Therapeutics, Inc., a radiopharmaceutical company advancing novel targeted alpha therapies for cancer, announced that the first patient has been treated in the second cohort of its Phase 1/2a dose-finding trial of [212Pb]PSV359. The study is evaluating the safety and preliminary anti-tumor activity of [212Pb]PSV359 in patients with solid tumors expressing fibroblast activation protein alpha (FAP-α). Patient selection for this therapy is supported by SPECT imaging with [203Pb]PSV359, enabling a personalized approach to treatment.

In this second cohort, patients are receiving 5.0 mCi of [212Pb]PSV359 for up to four doses administered every eight weeks. The Safety Monitoring Committee (SMC) recommended escalation to this higher dose after reviewing safety data from two patients treated at the lower 2.5 mCi dose level. The study aims to identify the optimal dose for balancing safety with therapeutic effect.

"Dosing the first patient in the second cohort marks an important step in advancing our evaluation of [212Pb]PSV359 for cancers expressing FAP-α," said Markus Puhlmann, Chief Medical Officer of Perspective. "FAP-α is found in a wide range of epithelial malignancies, including pancreatic cancer, colorectal cancer, and many sarcomas. Because of its multi-factorial biologic effects within the tumor microenvironment, it contributes to disease progression and negatively affects treatment response. These characteristics highlight the broad potential of PSV359 across multiple solid tumors. This study is helping us determine the optimal dose and indications to move forward, either as a monotherapy or in future combination strategies."

PSV359 was engineered to deliver 212Pb directly to FAP-α–expressing tumors, which are associated with several highly prevalent cancers where new treatment options are needed. The targeting ligand can also be labeled with 203Pb or 68Ga (PSV377) for imaging to confirm FAP-α expression in individual patients. Preclinical and early human imaging studies suggest improved tumor uptake, reduced healthy tissue retention, and a favorable therapeutic index, supporting PSV359’s potential as a next-generation radiopharmaceutical therapy.

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