Study of a New Technique for Imaging Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging in Pancreatic Cancer or Other CA19-9 Positive Malignancies

Conditions
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Pancreatic Cancer, Tumors That Express CA19-9

Intervention / Treatment
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* Drug: MVT-2163
* Drug: MVT-5873


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: This is a phase I, open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 (89Zr-DFO-HuMab-5B1) and varying antibody masses of MVT-5873 (HuMab-5B1), designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging. This trial will include dose escalation, which includes up to 5 cohorts, an expansion phase, a re-entry phase, and a pre-surgery phase.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 89Zr-DFO-HuMab-5B1 (MVT-2163) Imaging<br>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. | Drug: MVT-2163<br>* MVT-2163 is administered intravenously as a PET imaging agent.<br>* Other names: 89Zr-DFO-HuMab-5B1;Drug: MVT-5873<br>* MVT-5873 will be administered intravenously over at least 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-related adverse events as assessed | assessed by CTCAE v4.0 | 1 year | 
| Biodistribution of MVT-2163 | will be determined by measuring radiation exposure for key organs and tissues | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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89Zr-DFO-HuMab-5B1 (MVT-2163), Imaging, MVT-5873, 20-342