In this first-in human, phase I/IIa study, the safety and efficacy of \[212Pb\]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.
Ability to understand and willingness to provide informed consent, willingness to comply with all study procedures for the duration of the study
Aged ≥ 18 years
Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma
Previously progressed (radiological progression) on at least one approved systemic therapy for advanced melanoma
Active secondary malignancy
Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled
Pregnancy or breastfeeding a child
Any serious/active/uncontrolled infection requiring parenteral antibiotics within 2 weeks before the first administration of [212Pb]VMT01