Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

Melanoma (Skin) Clinical Trial

— TIMAR1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904120
• Other study ID #: TIMAR1
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: June 2022
• Source: Viewpoint Molecular Targeting
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Melanoma Stage IV
• Melanoma, Uveal

Intervention

Drug:
• [203Pb]VMT01
Diagnostic imaging radiopharmaceutical; by intravenous infusion
• [68Ga]VMT02
Diagnostic imaging radiopharmaceutical; by intravenous infusion

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Viewpoint Molecular Targeting	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).
Primary	Biodistribution of [68Ga]VMT02	Biodistribution will be calculated by utilizing PET/CT scans.	12 hours
Primary	Biodistribution of [203Pb]VMT01	Biodistribution will be calculated by utilizing SPECT/CT scans.	24 hours
Primary	Peak Plasma Concentration (Cmax) of [203Pb]VMT01	Cmax will be determined by blood sampling and direct radioactivity measurements.	24 hours
Primary	Area Under the Plasma Concentration Versus Time Curve (AUC) for [203Pb]VMT01	AUC will be determined by blood sampling and direct radioactivity measurements.	24 hours
Primary	Renal Excretion of [203Pb]VMT01	Renal excretion will be determined by urine sampling and direct radioactivity measurements.	24 hours
Primary	Modeling of [203Pb]VMT01 Dosimetry	Dosimetry will be modeled by utilizing the SPECT/CT scans.	24 hours
Secondary	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.	Historical tissue sample (collected <365 days before study enrollment) compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Secondary	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.	Historical imaging information compared to Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging
Secondary	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.	Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging