A Phase I Study of Pretargeted PET Imaging Using 64Cu-Tz-SarAr and a Trans-Cyclooctene-Modified Humanized 5B1 Immunoconjugate (hu5B1-TCO) in Patients With Pancreatic, Bladder Cancer, Gastrointestinal Malignancies or Solid Tumors With Elevated CA19-9
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 22
- 主要终点
- SUV mean measurement
研究概览
简要总结
The purpose of this study is to find the highest safe dose of hu5B1-TCO and the best dosing schedule of hu5B1-TCO and 64Cu-Tz-SarAr for finding cancer cells that are CA19-9 positive. This study will also help to find out how much radiation the body is exposed to when 64Cu-Tz-SarAr is used, and provide information on the way the body absorbs, distributes, and gets rid of 64Cu-Tz-SarAr.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for enrollment if they fulfill the following criteria:
- •Signed informed consent
- •18 years of age or older
- •Histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma/bladder carcinoma / gastrointestinal tumor reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) of
- •Patient with solid tumors increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy
- •4. At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects
- •ECOG performance status of 0 to 2
- •Adequate laboratory parameters including: i. Absolute neutrophil count (ANC) ≥1.5 x 109/L ii. Hemoglobin ≥ 9.0 g/dL iii. Platelet count >75,000/ mm3 iv. AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN v. Total bilirubin ≤ 1.5x the upper limit of normal unless considered due to Gilbert's syndrome in which case, ≤3x the upper limit of normal vi. Creatinine clearance (CLcr) (> 60 mL/min) estimated by the Cockcroft-Gault (C-G) equation or estimated glomerular filtration rate (eGFR)
- •Willingness to participate in collection of pharmacokinetic samples
排除标准
- •Patients will be excluded from the study if they fulfill any of the following criteria:
- •Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •Major surgery other than diagnostic surgery within 4 weeks of Study Day 1
- •History of anaphylactic reaction to human, or humanized, antibody
- •Other on-going cancer therapy with investigational agents
- •Known history of HIV
- •Pregnant or currently breast-feeding
- •a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the study and for 1 week following the study treatment.
- •Psychiatric illness/social situations that would interfere with compliance with study requirements.
研究组 & 干预措施
Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
干预措施: 64Cu-Tz-SarAr (Drug)
Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
干预措施: hu5B1-TCO (Drug)
Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
干预措施: Pharmacokinetics (Diagnostic Test)
Participants with Pancreatic Cancer
Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma
干预措施: PET Scan (Diagnostic Test)
结局指标
主要结局
SUV mean measurement
时间窗: 28 months
The serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected
次要结局
未报告次要终点