89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- Number of subjects with treatment-related adverse events as assessed
研究概览
简要总结
The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of 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
- All
- 接受健康志愿者
- 否
入选标准
- •PART I : ESCALATION, EXPANSION, RE-ENTRY COHORTS:
- •Histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
- •PART II: PRE-SURGERY COHORT ONLY:
- •Patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3)
- •Patients scheduled referred to surgery or biopsy as standard of care for their pancreatic adenocarcinoma OR
- •Patients with Intraductal papillary mucinous neoplasm (IPMN) referred to surgery or biopsy as standard of care.
- •The suspicion for pancreatic carcinoma and decision for surgery or biopsy will be based on review of imaging and clinical findings in the disease management team discussion including surgeon and radiologist.
- •PART I and II:
- •Signed, informed consent
- •Age 18 or more years
- •At least one lesion by CT or MRI ≥ 2 cm, unless determine otherwise for pre-surgery cohort subjects
- •CA19-9 serum level:
- •For Part I: >ULN or CA19-9 positive biopsy (optional);
- •For Part II ( presurgical cohort): CA19-9 serum level (normal or high levels are allowed) or CA19-9 positive biopsy (optional)
- •ECOG performance status of 0 to 2
- •Adequate laboratory parameters including:
- •Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
- •Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
- •Platelet count >75,000/ mm^3
- •AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0 x ULN
- •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
- •Creatinine (serum or plasma) ≤ 1.5 x ULN or eGFR>50 mL/min
- •PART I: ESCALATION, EXPANSION, RE-ENTRY COHORTS:
- •Willingness to participate in collection of pharmacokinetic samples
排除标准
- •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 or investigational agents (except MVT-5873)
- •Known history of HIV
- •Pregnant or currently breast-feeding
- •Psychiatric illness/social situations that would interfere with compliance with study requirements
- •Prior entry onto this protocol 3 or more times (e.g., subjects may enter this protocol and be imaged up to 3 times)
研究组 & 干预措施
89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging
All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, ~ 2 hours, and ~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.
干预措施: MVT-2163 (Drug)
89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging
All subjects will receive a single, fixed, intravenous dose of MVT-2163, consisting of 3 mg (nominal mass - actual mass administered will likely vary between 2.0 and 2.5 mg) of MVT-2163 radiolabeled from 5 mCi to no less than 1.0 mCi (adjusted as of 16-Mar 2017) of 89Zr.Cohort 1 subjects will receive MVT-2163, with no MVT-5873 pre-dosing. Subjects in subsequent cohorts 2 and 3 will receive a dose of MVT-5873 15 minutes, ~ 2 hours, and ~4 hours prior to administration of MVT-2163. Future cohorts 4 and 5 may evaluate alternate time frames. Other cohorts may evaluate administration of MVT-5873 one week prior (D-7) to the day of MVT-2163 administration and a second administration of MVT-5873 the day of (D0) MVT-2163 administration. The re-entry (RE) and pre-surgery (PS) cohorts will administer MVT-2163 3 ± 1 hour after administration of MVT-5873.
干预措施: MVT-5873 (Drug)
结局指标
主要结局
Number of subjects with treatment-related adverse events as assessed
时间窗: 1 year
assessed by CTCAE v4.0
Biodistribution of MVT-2163
时间窗: 1 year
will be determined by measuring radiation exposure for key organs and tissues
次要结局
未报告次要终点