Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

This is a first-in-human study evaluating the suitability of [203Pb]VMT01 for SPECT/CT imaging and [68Ga]VMT02 for PET/CT imaging of MC1R-expressing metastatic melanoma. Study results will provide foundational data to develop imaging and dosing for future therapeutic trials of [212Pb]VMT01 for the treatment of metastatic melanoma.

The study will be a cross-over study with the participants serving as their own comparator. Participants with positive FDG-PET scans for stage IV (or inoperable stage III) metastatic melanoma will undergo SPECT/CT scans utilizing [203Pb]VMT01 followed a few weeks later by PET/CT scans utilizing [68Ga]VMT02, or vice versa. The order of the imaging agents will be randomly assigned.

Inclusion criteria

• Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
• Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment
• Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
• Ability to lie flat and still for a minimum of two hours for imaging
• Male and female participants with reproductive potential must agree to use highly effective contraception in preparation of the study, during the study, and for 4 weeks following the last dose of an investigative imaging agent
• Documented life expectancy of at least 3 months

Exclusion criteria

• Active secondary malignancy
• Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable
• Pregnancy or breast feeding a child
• Uncontrolled infection
• Treatment with another investigational drug within 30 days prior to enrollment date
• Any treatment with BRAF inhibitors since the baseline FDG-PET scan or plans for such treatment during the study
• Kidney function not within protocol limits
• BMI>40 kg/m2
• History of a condition resulting in anaphylaxis or angioedema