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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of [203Pb]VMT01
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Archived tumor tissue will be tested for expression of the imaging target, melanocortin receptor sub-type 1 (MC1R). The qualified researcher who tests the sample, and the independent pathologist who reviews the results, will be blinded to a participant's identifying information and imaging results. Evaluators will not have access to the medical record.
A pool of three qualified readers will evaluate study images (PET/CT and SPECT/CT). Images and medical information given to the readers will not include a participant's identifying information. The reader pool will not know the sequence of imaging for a participant or have access to the medical record.
An independent medical physicist will validate imaging results and measurements of radiation absorbed and excreted by the participant's body. The physicist will be blinded to participant identifiers and demographics, as well as the sequence of imaging for a participant. The physicist will not have access to the medical record.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Kidney function not within protocol limits
- •BMI>40 kg/m2
- •History of a condition resulting in anaphylaxis or angioedema
研究组 & 干预措施
[203Pb]VMT01 first
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.
干预措施: [203Pb]VMT01 (Drug)
[203Pb]VMT01 first
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.
干预措施: [68Ga]VMT02 (Drug)
[68Ga]VMT02 first
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.
干预措施: [203Pb]VMT01 (Drug)
[68Ga]VMT02 first
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.
干预措施: [68Ga]VMT02 (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of [203Pb]VMT01
时间窗: 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
时间窗: 24 hours
AUC will be determined by blood sampling and direct radioactivity measurements.
Number of Participants with Study Imaging Agent-Associated Adverse Events (AE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
时间窗: 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
时间窗: 12 hours
Biodistribution will be calculated by utilizing PET/CT scans.
Biodistribution of [203Pb]VMT01
时间窗: 24 hours
Biodistribution will be calculated by utilizing SPECT/CT scans.
Renal Excretion of [203Pb]VMT01
时间窗: 24 hours
Renal excretion will be determined by urine sampling and direct radioactivity measurements.
Modeling of [203Pb]VMT01 Dosimetry
时间窗: 24 hours
Dosimetry will be modeled by utilizing the SPECT/CT scans.
次要结局
- MC1R Expression Correlation Between Archived Tumor Tissue and Study Imaging(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(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(Visit 1 (Day 1) and Visit 3 (Day 21-34) imaging)