Perspective Therapeutics (CATX) announced that alignment was reached with the U.S. Food and Drug Administration, FDA, to open the third dosing cohort of its ongoing Phase 1/2a clinical trial for 212PbVMT-alpha-NET in patients with unresectable or metastatic somatostatin receptor 2, SSTR2,-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies. Patients in Cohort 3 will receive up to four fixed administered doses of 212PbVMT-alpha-NET at 6 mCi every eight weeks if they weigh more than 60kg, or 100muCi/kg of body weight if they weigh less than or equal to 60kg. Observations of dose limiting toxicities, DLTs, in up to eight patients within 42 days of the first treatment cycle will be used to assess whether this cohort of patients have received maximum tolerated dose, MTD, or maximum feasible dose, MFD. Once a safety monitoring committee, SMC, has reviewed the data from these initial patients, it may recommend exploring alternative dosing and/or recruit more patients into Cohort 3.
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