Clinical trial NCT04904120: Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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)
Positron Emission Tomography (PET)
Melanocortin Receptor Sub-type 1 (MC1R)
VMT01
VMT02
Pb-203
Ga-68
Cancer
Immunohistochemistry (IHC)
Lead sponsor: Perspective Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Mayo Clinic
First posted: 2021-05-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent
2. Baseline fluorodeoxyglucose (FDG)-PET scan available from within 30 days prior to date of enrollment
3. Blood counts and metabolic results within protocol limits within 14 days prior to enrollment
4. Ability to lie flat and still for a minimum of two hours for imaging
5. 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
6. Documented life expectancy of at least 3 months

Exclusion Criteria:

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

Primary outcomes:
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.
timeFrame: 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).
measure: Biodistribution of [68Ga]VMT02
timeFrame: 12 hours
measure: Biodistribution of [203Pb]VMT01
timeFrame: 24 hours
measure: Peak Plasma Concentration (Cmax) of [203Pb]VMT01
timeFrame: 24 hours
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01
timeFrame: 24 hours
measure: Renal Excretion of [203Pb]VMT01
timeFrame: 24 hours
measure: Modeling of [203Pb]VMT01 Dosimetry
timeFrame: 24 hours
Secondary outcomes:
measure: MC1R Expression Correlation Between Archived Tumor Tissue and Study Imaging
timeFrame: Historical tissue sample (collected <365 days before study enrollment) compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
measure: Cancer Site Correlation Between Standard of Care Imaging Compared to Study Imaging
timeFrame: Historical imaging information compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
measure: 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
timeFrame: Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Perspective Therapeutics
name: Frances L Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Geoffrey B Johnson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: