NEW YORK – Perspective Therapeutics said on Friday that it has treated the first metastatic melanoma patient in its Phase I/IIa radiopharmaceutical trial of 212Pb-VMT01.
In the first-in-human trial, Richland, Washington-based Perspective is assessing its targeted alpha therapy 212Pb-VMT01 as a treatment for patients with melanocortin 1 receptor (MC1R)-positive metastatic melanoma.
To confirm MC1R tumor expression for trial eligibility, patients must undergo PET or SPECT imaging with one of the MC1R-targeting diagnostic agents 68Ga-VMT02 or 203Pb-VMT01.
The Phase I/IIa study has a dose-escalation portion, through which Perspective will assess the maximum-tolerated dose or maximum-feasible dose of 212Pb-VMT01 . Subsequently, the trial will enter a dose-expansion portion, in which Perspective will test 212Pb-VMT01's activity at the maximum dose determined in the earlier part of the study. Additionally, the firm plans to conduct a dosimetry sub-study, in which it will use the 203Pb-VMT01 imaging agent to measure normal organ biodistribution, tumor uptake, radiation dosimetry, and the relationship between the dose, toxicities, and efficacy.
The trial, which is expected to include 52 patients, will take place at Yale University, University of Iowa, Mayo Clinic, Saint Louis University, Washington University, and the University of Wisconsin.
"MC1R is implicated in the development of melanoma, making it a promising target for potential treatment using radionuclide therapy," Perspective CEO Thijs Spoor said in a statement. "Today, we achieved an important milestone as we work to access the potential of VMT01 as a targeted alpha-particle therapy for MC1R-positive metastatic melanoma."
Perspective, previously called Viewpoint Molecular Targeting, generated the lead-212 radioisotope in the therapy using its desktop generator, VMT-α-GEN, and then assembled the rest of the product at its manufacturing facility. The firm is planning to expand its capacity to develop the product in the US by adding manufacturing sites via contract development and manufacturing organizations.