A Phase 0 Study of the Pharmacokinetics and Biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds With and Without PTI-122 in Patients With Metastatic Prostate Cancer to Inform Future Phase 1 Dosing With [Ac-225]-Trillium-PSMA Radionuclide Therapy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Amount of radiotracer absorbed by organs
研究概览
简要总结
Exploratory study in adult males with metastatic prostate cancer intended to characterize the pharmacokinetics and biodistribution of PSMA-Targeted [In-111]-Labeled Trillium Compounds with and without the cytoprotective agent PTI-122. Up to 36 eligible subjects will be enrolled. Additional subjects may be enrolled if there is insufficient data for evaluation, for example if the original study subjects do not complete required imaging studies for reasons unrelated to adverse events.
Up to four PSMA-Targeted [In-111]-Labeled Trillium Compounds will be evaluated. Each compound will be evaluated first without the cytoprotective agent, PTI-122, then the [In-111]-labeled Trillium Compound may be co-administered with PTI-122.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males with metastatic prostate cancer
- •ECOG performance score 0-2
- •Stable androgen deprivation or other hormone therapy (30 days) or therapy planned but not yet initiated
- •PSMA PET scan between 3 and 28 days prior to radiotracer injection with at least 2 PSMA positive lesions and either:
- •One soft tissue lesion measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ SUVmean normal liver, OR
- •Two bone lesions measuring ≥ 15 mm in the longest diameter with SUVmax lesion ≥ 2 x SUVmax normal liver
- •Able to understand and adhere to study requirements, and voluntarily give informed consent
排除标准
- •No other malignancy undergoing treatment
- •No PSMA-targeted therapy ongoing
- •Inability or unwillingness to undergo SPECT/CT imaging
- •Serum creatinine > 1.5 mg/dL or creatinine clearance ≤50 mL/min by Cockcroft-Gault estimation
- •Concurrent participation in the active treatment phase of another clinical trial of investigational medicinal product(s)
- •Significant intercurrent illness, treatment-related toxicity, or psychiatric illness/social situation that could place the subject at undue risk during study participation, significantly alter study outcomes, or affect subject compliance with study requirements for dosing and evaluation, as determined by the investigator
研究组 & 干预措施
Trillium Compound Alone
Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound
干预措施: PSMA-Targeted [In-111]-Labeled Trillium Compound (Drug)
Trillium Compound + Single Dose PTI-122
Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
干预措施: PSMA-Targeted [In-111]-Labeled Trillium Compound (Drug)
Trillium Compound + Single Dose PTI-122
Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus single dose of PTI-122 at 5, 10 or 15 mg
干预措施: PTI-122 (Drug)
Trillium Compound + Multiple Dose PTI-122
Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level
干预措施: PSMA-Targeted [In-111]-Labeled Trillium Compound (Drug)
Trillium Compound + Multiple Dose PTI-122
Single dose of PSMA-Targeted [In-111]-Labeled Trillium Compound plus two doses of PTI-122 at the preferred dose level
干预措施: PTI-122 (Drug)
结局指标
主要结局
Amount of radiotracer absorbed by organs
时间窗: Over 168 hours post-injection
Organ uptake measured on imaging
Amount of radioactivity in blood
时间窗: Over 168 hours post-injection
Radioactivity measured pre- and post-radiotracer injection
Amount of radiotracer absorbed by tumor
时间窗: Over 168 hours post-injection
Tumor uptake measured on imaging
次要结局
- Incidence of adverse events(Over 168 hours post-injection)
- Amount of PTI-122 in blood(Over 168 hours post-injection)