A Phase 1 interventional study of [203Pb]VMT01 and [68Ga]VMT02 in Melanoma (Skin), Melanoma Stage IV and Melanoma, Uveal, sponsored by Perspective Therapeutics. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Perspective Therapeutics · Phase 1, Interventional, and Diagnostic
The study hypothesis is that new imaging agents [203Pb]VMT01 and [68Ga]VMT02 can be safely used in humans without independent biological effect and can be used to image melanoma tumors expressing the melanocortin sub-type 1 receptor (MC1R) by SPECT/CT and PET/CT imaging modalities respectively.
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.
Exclusion Criteria:
Participants randomized to this arm will receive imaging agent \[203Pb\]VMT01 and undergo SPECT/CT imaging first. Later, participants in this arm will receive \[68Ga\]VMT02 and undergo PET/CT imaging.
Drug: [203Pb]VMT01 · Drug: [68Ga]VMT02
Participants randomized to this arm will receive imaging agent \[68Ga\]VMT02 and undergo PET/CT imaging first. Later, participants in this arm will receive \[203Pb\]VMT01 and undergo SPECT/CT imaging.
Drug: [203Pb]VMT01 · Drug: [68Ga]VMT02
Diagnostic imaging radiopharmaceutical; by intravenous infusion
Diagnostic imaging radiopharmaceutical; by intravenous infusion
Number of Participants with Study Imaging Agent-Associated Adverse Events (AE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Adverse Events (AEs) will be assessed for severity according to CTCAE v5.0 and for relatedness to each of the investigative imaging agents (\[203Pb\]VMT01 and \[68Ga\]VMT02). Assessments attributed as possibly, probably, or definitely related to the imaging agent will be considered related.
Time frame: Visit 1 (Day 1) through Visit 5 (approximately Day 60 but could extend up to Day 108); ongoing Serious Adverse Events (SAE) will be followed for no longer than Day 65 or 30 days from the date of the SAE report (whichever is later).
Biodistribution of [68Ga]VMT02
Biodistribution will be calculated by utilizing PET/CT scans.
Time frame: 12 hours
Biodistribution of [203Pb]VMT01
Biodistribution will be calculated by utilizing SPECT/CT scans.
Time frame: 24 hours
Peak Plasma Concentration (Cmax) of [203Pb]VMT01
Cmax will be determined by blood sampling and direct radioactivity measurements.
Time frame: 24 hours
Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01
AUC will be determined by blood sampling and direct radioactivity measurements.
Time frame: 24 hours
Renal Excretion of [203Pb]VMT01
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Time frame: 24 hours
Modeling of [203Pb]VMT01 Dosimetry
Dosimetry will be modeled by utilizing the SPECT/CT scans.
Time frame: 24 hours
MC1R Expression Correlation Between Archived Tumor Tissue and Study Imaging
Archived (previously collected) tumor tissue will be tested for MC1R expression and compared to study images obtained using MC1R targeted imaging agents, \[203Pb\]VMT01 and \[68Ga\]VMT02. The data will be assessed for an association between positive tissue and positive images.
Time frame: Historical tissue sample (collected <365 days before study enrollment) compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Cancer Site Correlation Between Standard of Care Imaging Compared to Study Imaging
Sites of cancer detected previously by imaging will be compared to the presence or absence of positive imaging scans with the study agents, \[203Pb\]VMT01 and \[68Ga\]VMT02.
Time frame: Historical imaging information compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Dosimetry will be Calculated for each Study Imaging Agent by Measuring the Cumulative Absorbed Dose of Radiation to the Participant's Individual Organs and Tumors
For a given participant, dosimetry calculations will be compared between the two imaging agents with respect to cumulative absorbed dose of radiation.
Time frame: Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Plan to share: Yes — All de-identified individual participant data (IPD) that underlies results in a peer-reviewed scientific publication will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Perspective Therapeutics