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
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Among 190 studies in Uveal Melanoma with a site in United States — 25 open to participants now, 50 under way, 7 of them phase 3. Uveal Melanoma · United States.
Among the 190 studies in Uveal Melanoma with a site in United States, this one is the 144th largest by enrollment of the 162 interventional ones that give a count, is one of 12 that started in 2021, is one of 53 in phase 1, and was the 145th registered.
281 studies on the registry are indexed under Uveal Melanoma; 50 are open to participants now.
Browse Uveal Melanoma studies →25 of the 190 studies in Uveal Melanoma with a site in United States are open now. Recruiting first, the newest first:
IDEAYA Biosciences · Sites in United States, Australia, Canada and 3 more countries
Ages 18+
VM Discovery, Inc. · Sites in United States
Ages 18–75
Massachusetts General Hospital · Sites in United States
Ages 18+
IDEAYA Biosciences · Sites in United States, Australia, Austria and 18 more countries
Ages 18+
H. Lee Moffitt Cancer Center and Research Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 42 Uveal Melanoma studies recruiting now, 35 (83%) set no upper age limit and 4 (10%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
190 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 73 · Phase 2 101 · Phase 3 12 · Phase 4 1
First in 1996; this study’s year is marked. 12 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 37 across 222 interventional studies indexed under Uveal Melanoma.
Median enrollment 36 across the 162 interventional studies, 79 across the 18 observational. Of the 130 that completed or were terminated, 58 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
56 of 190 have an industry lead sponsor. The 10 most frequent:
Perspective Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Perspective Therapeutics has 1 study filed under Uveal Melanoma — fewer than ten, so there is no comparison to draw.
16 of the studies in Uveal Melanoma with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05987332Phase 3IDEAYA BiosciencesIDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma | 2027-01-15 |
| NCT06007690Phase 3Aura BiosciencesA Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma | 2027-11-15 |
| NCT01587352National Cancer Institute (NCI)Vorinostat in Treating Patients With Metastatic Melanoma of the Eye | 2026-12-31 |
| NCT03947385IDEAYA BiosciencesStudy of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions | 2027-01-29 |
| NCT04728633Thomas Jefferson UniversityTransarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases | 2027-01-31 |
Add all 16 to your calendar (.ics) → With an account.
Among the 190 studies in Uveal Melanoma with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
281 studies on the registry are indexed under Uveal Melanoma; 50 are open to participants now.
This study's enrollment of 7 is below the median of 37 across 222 interventional studies indexed under Uveal Melanoma.
Browse Uveal Melanoma studies →Perspective Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Compared within Uveal Melanoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Melanoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Mar 2021 to primary completion in Sep 2022, 18 months.
Of 32 phase 1 interventional studies under Uveal Melanoma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 66. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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