Melanoma (Skin)Phase 1TIMAR1NCT04904120
Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
A Phase 1 study testing [203Pb]VMT01 and [68Ga]VMT02 in people with Melanoma (Skin) and Melanoma Stage IV, run by Perspective Therapeutics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Melanoma (Skin), Melanoma Stage IV, Melanoma, Uveal
- What is being tested?
- [203Pb]VMT01 and [68Ga]VMT02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 20 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Kidney function not within protocol limits
- BMI>40 kg/m2
- History of a condition resulting in anaphylaxis or angioedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Cross-over Biodistribution Study of [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) Imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) Imaging of Stage IV Metastatic Melanoma
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.
Read the detailed description
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.
- Conditions
- Melanoma (Skin), Melanoma Stage IV, Melanoma, Uveal, Melanoma, Mucosal
- Being tested
- [203Pb]VMT01, [68Ga]VMT02
- Keywords
- Melanoma, Theranostic, Radiopharmaceutical, Radiotherapy, Alpha-Particle, Diagnostic, Metastatic, Single Photon Emission Computed Tomography (SPECT), Positron Emission Tomography (PET), Melanocortin Receptor Sub-type 1 (MC1R), VMT01, VMT02, Pb-203, Ga-68, Cancer, Immunohistochemistry (IHC)
- Medical subject headings
- Melanoma, Uveal Melanoma, Disease, Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[203Pb]VMT01Drug
Diagnostic imaging radiopharmaceutical; by intravenous infusion
[68Ga]VMT02Drug
Diagnostic imaging radiopharmaceutical; by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| [203Pb]VMT01 first | Active comparator | 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. Receives: Drug: [203Pb]VMT01; Drug: [68Ga]VMT02 |
| [68Ga]VMT02 first | Active comparator | 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. Receives: Drug: [203Pb]VMT01; Drug: [68Ga]VMT02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 hours
Biodistribution of [203Pb]VMT01
Biodistribution will be calculated by utilizing SPECT/CT scans.
Measured: 24 hours
Peak Plasma Concentration (Cmax) of [203Pb]VMT01
Cmax will be determined by blood sampling and direct radioactivity measurements.
Measured: 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.
Measured: 24 hours
Renal Excretion of [203Pb]VMT01
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Measured: 24 hours
Modeling of [203Pb]VMT01 Dosimetry
Dosimetry will be modeled by utilizing the SPECT/CT scans.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start5 Mar 2021
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perspective Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Frances L Johnson, MD, Principal investigator, Perspective TherapeuticsGeoffrey B Johnson, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904120
- Sponsor's protocol ID
- TIMAR1
- Acronym
- TIMAR1
- Status last verified
- Jun 2022
- First submitted
- 3 May 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data (IPD) that underlies results in a peer-reviewed scientific publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Cross-over Biodistribution Study of [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) Imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) Imaging of Stage IV Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT04904120
- Acronym / sponsor ID
- TIMAR1 / TIMAR1
- Conditions
- Melanoma (Skin), Melanoma Stage IV, Melanoma, Uveal, Melanoma, Mucosal
- Keywords
- Melanoma, Theranostic, Radiopharmaceutical, Radiotherapy, Alpha-Particle, Diagnostic, Metastatic, Single Photon Emission Computed Tomography (SPECT)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Perspective TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [203Pb]VMT01 first | Active comparator | Drug: [203Pb]VMT01, Drug: [68Ga]VMT02Participants 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. |
| [68Ga]VMT02 first | Active comparator | Drug: [203Pb]VMT01, Drug: [68Ga]VMT02Participants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [203Pb]VMT01Diagnostic imaging radiopharmaceutical; by intravenous infusion | Drug | [203Pb]VMT01 first, [68Ga]VMT02 first |
| [68Ga]VMT02Diagnostic imaging radiopharmaceutical; by intravenous infusion | Drug | [203Pb]VMT01 first, [68Ga]VMT02 first |
Primary outcome
Number of Participants with Study Imaging Agent-Associated Adverse Events (AE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
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).
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.
Biodistribution of [68Ga]VMT02
Time frame: 12 hours
Biodistribution will be calculated by utilizing PET/CT scans.
Biodistribution of [203Pb]VMT01
Time frame: 24 hours
Biodistribution will be calculated by utilizing SPECT/CT scans.
Peak Plasma Concentration (Cmax) of [203Pb]VMT01
Time frame: 24 hours
Cmax will be determined by blood sampling and direct radioactivity measurements.
Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01
Time frame: 24 hours
AUC will be determined by blood sampling and direct radioactivity measurements.
Renal Excretion of [203Pb]VMT01
Time frame: 24 hours
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Modeling of [203Pb]VMT01 Dosimetry
Time frame: 24 hours
Dosimetry will be modeled by utilizing the SPECT/CT scans.
3 secondary outcomes
MC1R Expression Correlation Between Archived Tumor Tissue and Study Imaging
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
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
Time frame: Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data (IPD) that underlies results in a peer-reviewed scientific publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frances L Johnson, MD principal investigator
Perspective Therapeutics
Geoffrey B Johnson, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [203Pb]VMT01 and [68Ga]VMT02 in people with Melanoma (Skin) and Melanoma Stage IV, run by Perspective Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Study Imaging Agent-Associated Adverse Events (AE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. (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).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.