Perspective Therapeutics announces the first patient was dosed at the University of Wisconsin in the Company’s Phase 1/2a dose escalation trial evaluating the safety and efficacy of 212Pb-VMT01 in patients with MC1R+ metastatic melanoma. The trial is a first-in-human, non-randomized, multi-center open-label dose escalation, dose expansion study of 212Pb-VMT01 in patients with histologically confirmed melanoma and a positive MC1R imaging scan.VMT01 has recently completed clinical imaging studies at Mayo Clinic, Rochester. Results were presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Chicago. In addition, published preclinical data demonstrated durable complete responses in treatment-resistant models when combined with existing immunotherapy drugs used to treat melanoma. The Phase 1/2a study consists of a dose-escalation part designed to determine the Maximum Tolerated Dose or Maximum Feasible Dose following a single administration of 212Pb-VMT01 followed by a dose expansion based on the identified MTD/MFD for the selection of dose for further clinical development. Patients may be eligible to receive up to 3 administrations of 212Pb-VMT01 approximately 8 weeks apart. A dosimetry sub-study utilizing the SPECT imaging surrogate, 203Pb-VMT01, has been added to assess normal organ biodistribution, tumor uptake, radiation dosimetry, and correlation of uptake with observed toxicities and efficacy. Clinical trial sites include Yale University, University of Iowa, Mayo Clinic in Rochester, Saint Louis University, Washington University, and University of Wisconsin.
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