Core Viewpoint - Perspective Therapeutics, Inc. has reached an agreement with the FDA to open the third dosing cohort of its Phase 1/2a clinical trial for [Pb]VMT-α-NET, targeting patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not previously received radiopharmaceutical therapies [1][2] Group 1: Clinical Trial Details - Cohort 3 will administer up to four fixed doses of [Pb]VMT-α-NET at 6 mCi every eight weeks for patients over 60 kg, or 100 μCi/kg for those 60 kg or under [2] - The trial will assess dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle to determine maximum tolerated dose (MTD) or maximum feasible dose (MFD) [2] - Recruitment for Cohort 3 is now open, and patients currently evaluated for entry will enroll if they qualify [3] Group 2: Product and Technology Overview - [Pb]VMT-α-NET is designed to target and deliver lead (Pb) to tumor sites expressing SSTR2, with a multi-center, open-label, dose-escalation study ongoing [4] - The company employs a "theranostic" approach, utilizing alpha-emitting isotopes to deliver radiation specifically to cancer cells while also developing complementary imaging diagnostics [5] - The ongoing programs for melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) are in Phase 1/2a trials in the U.S. [6] Group 3: Future Plans and Updates - The company plans to submit further clinical updates to scientific congresses in the second half of 2025, including safety follow-up data and anti-tumor activity results [6] - A dosimetry sub-study analysis is scheduled to be presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting [6]
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial