²¹²Pb-VMT01 is intended for the treatment of MC1R-positive metastatic melanoma. Credit: Kateryna Kon / Shutterstock.

Medical technology and radiopharmaceutical company Perspective Therapeutics has enrolled the first patient cohort in its Phase I/IIa dose escalation study of ²¹²Pb-VMT01 to treat MC1R-positive metastatic melanoma.

The dose escalation and dose expansion study enrolled subjects with histologically confirmed melanoma and positive MC1R imaging scans.

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Its first portion is a dose escalation phase that aims to determine the maximum tolerated radioactivity dose (MTD) or maximum feasible radioactivity dose (MFD) after a single administration of ²¹²Pb-VMT01.

Patients with Stage IV or unresectable Stage III metastatic melanoma that had advanced after receiving at least one approved first-line therapy have been enrolled in the study.

They will receive up to three administrations of ²¹²Pb-VMT01 around eight weeks apart.

The first patient cohort will receive 111 megabecquerels (MBq) for each dose, while patients in the second cohort will be given 185MBq.

If the MTD or MFD is not reached during escalation, 370MBq and 555MBq will be given to the third and fourth cohorts respectively.

In line with the Modified Toxicity Probability Interval II (mTPI-2) study design, intermediate de-escalation doses are also possible to allow the best activity dose to be chosen.

The second portion of the trial is its dose-expansion phase, in which patients may be eligible for up to three administrations of ²¹²Pb-VMT01 around eight weeks apart.

It also includes a dosimetry sub-study, which will evaluate biodistribution, tumour uptake and the correlation of this uptake with observed toxicities and efficacy.

Perspective Therapeutics chief medical officer Markus Puhlmann said: “We are encouraged by the pace of enrolment in the trial, which we believe is indicative of the tremendous unmet need for patients with unresectable and intractable melanomas.

“We are grateful to our clinical collaborators for their diligence in working closely with patients to deliver our targeted alpha-particle therapy, and we look forward to providing an update in the coming months.”