Perspective Therapeutics
This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
This is a prospective, multi-center, open-label, radioactivity dose-finding/ dose expansion study of \[212Pb\]VMT-α-NET in up to approximately 300 adult subjects with unresectable or metastatic SSTR2-expressing tumors who have not received prior peptide receptor radionuclide therapy (PRRT). Somatostatin Receptor type 2 (SSTR2) is highly expressed on various tumors including Neuroendocrine tumors (NETs), meningioma and therefore is an attractive therapeutic target. Lead-212 (\[212Pb\]-) based peptide-radiopharmaceuticals are an emerging class of targeted alpha-particle cancer therapies that ha…
Inclusion Criteria: 1. Adult (ages ≥18) PRRT-naïve subjects with NETs or meningioma by local pathology. 2. Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or paragangliomas for the dose-expansion part of the study (c) Requiring at least 1 prior surgery (resection/biopsy) and a maximum of 1 line of EBRT, if technically feasible, for meningioma. 3. For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1…
\[203Pb\]VMT-α-NET is administered by intravenous bolus injection for single-photon emission computed tomography imaging.
\[212Pb\]VMT-α-NET is administered by intravenous infusion for treatment of SSTR2 expressing tumors.