A Phase I/IIA Study of PET Imaging With 89Zr-Df-IAb2M in Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
研究概览
简要总结
This is a Phase I/IIa study evaluating the safety and feasibility of [89Zr]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of [89Zr]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of [89Zr]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.
详细描述
IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 male >/= 18 years of age
- •Patients with histologically confirmed prostate cancer
- •Progressive disease manifest (within 6 weeks of screening) by either
- •imaging modalities (bone scan, MRI or CT) OR
- •biochemical progression (PSA)
- •Performance status of 60 or higher on Karnofsky scale
- •Subject's schedule permits compliance with all study procedures
- •Ability to understand and willingness to sign a written informed consent form
排除标准
- •Previous anaphylactic reaction to huJ591 antibody or FDG imaging
- •On any new anticancer therapy (GnRH analog allowed) while on the study
- •Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
- •Renal lab values: Creatinine > 1.5 ULN
- •Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration
结局指标
主要结局
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.
时间窗: Day 1 (Infusion Day) through Day 7
To assess the safety of a single dose of of \[89Zr\]Df-IAB2M
次要结局
- [89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer(Day 1 (Infusion Day) to Day 3)
- Optimal parameters for imaging with [89Zr]Df-IAB2M(Day 1 (Infusion Day) to Day 3)
- Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer(Up to 4 weeks)