PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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 CA19-9-Positive Pancreatic Cancer

Conditions
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Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: PET Scan
* Drug: hu5B1-TCO
* Drug: 64Cu-Tz-SarAr
* Diagnostic Test: Pharmacokinetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 reviewed at MSK - includes patients with biopsy-proven or high suspicion on imaging for pancreatic ductal adenocarcinoma (PDAC) (Stage T2 and T3) or histologically confirmed, locally-advanced, or metastatic pancreatic ductal adenocarcinoma (PDAC). Patients who are surgical candidates for tumor resection or for biopsy or patients with metastatic disease, who are to undergo biopsy prior to standard of care treatment. Patients who have received neoadjuvant chemotherapy or radiation therapy who are scheduled to undergo surgery are eligible At least one lesion by CT or MRI ≥ 2 cm unless determined otherwise for presurgery subjects Patient with increased serum CA19-9 serum level greater than ULN or CA19-9 positive biopsy 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 Exclusion Criteria: 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.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Pancreatic Cancer<br>Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma | Diagnostic Test: PET Scan<br>* Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination<br>Drug: hu5B1-TCO<br>* On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.<br>Drug: 64Cu-Tz-SarAr<br>* On study day 0, a single slow infusion of hu5B1-TCO will be administered intravenously. Subsequently, either 3 days (n = 3) or 5 days (n = 3) later, a single slow infusion of 64Cu-Tz-SarAr will be administered intravenously.<br>Diagnostic Test: Pharmacokinetics<br>* All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV mean measurement | 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 | 28 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma, Primary Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, hu5B1-TCO, 64Cu-Tz-SarAr, 20-409, Memorial Sloan Kettering Cancer Center