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Clinical Trial Record

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PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

2023-02-10

2026-02-10

2026-02-10

0

Study Overview

PET Imaging Using 64Cu-Tz-SarAr and hu5B1-TCO in People With Pancreatic, Colorectal, Bladder Cancer or Cancers With Elevated CA19.9

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.

N/A

  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Ductal Adenocarcinoma
  • Primary Pancreatic Ductal Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • DIAGNOSTIC_TEST: PET Scan
  • DRUG: hu5B1-TCO
  • DRUG: 64Cu-Tz-SarAr
  • DIAGNOSTIC_TEST: Pharmacokinetics
  • 20-409

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-02-10  

N/A  

2025-08-27  

2023-02-10  

N/A  

2025-09-04  

2023-02-21  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Participants with Pancreatic Cancer

Participants have histologically confirmed primary or metastatic pancreatic ductal adenocarcinoma

DIAGNOSTIC_TEST: PET Scan

  • Participants will be imaged up to 4 time points post-injection to allow for biodistribution and dosimetry determination

DRUG: hu5B1-TCO

  • 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.

DRUG: 64Cu-Tz-SarAr

  • 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.

DIAGNOSTIC_TEST: Pharmacokinetics

  • All participants receiving 64Cu-Tz-SarAr will have serial blood samples drawn.
Primary Outcome MeasuresMeasure DescriptionTime Frame
SUV mean measurementThe serial quantitative data obtained over the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected28 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    Patients will be eligible for enrollment if they fulfill the following criteria:
    1. Signed informed consent 2. 18 years of age or older 3. 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 5. ECOG performance status of 0 to 2 6. 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) 10. 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:
    1. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy 2. Major surgery other than diagnostic surgery within 4 weeks of Study Day 1 3. History of anaphylactic reaction to human, or humanized, antibody 4. Other on-going cancer therapy with investigational agents 5. Known history of HIV 6. 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. 7. Psychiatric illness/social situations that would interfere with compliance with study requirements.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Somali Gavane, MD, Memorial Sloan Kettering Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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