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Clinical Trial Record

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Study of a New Technique for Imaging Pancreatic Cancer

2021-05-10

2025-01-27

2025-01-27

4

Study Overview

Study of a New Technique for Imaging Pancreatic Cancer

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.

N/A

  • Pancreatic Cancer
  • Tumors That Express CA19-9
  • DRUG: MVT-2163
  • DRUG: MVT-5873
  • 20-342

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

2021-05-10  

N/A  

2025-01-29  

2021-05-10  

N/A  

2025-01-30  

2021-05-12  

N/A  

2025-01  

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: 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-Ma

DRUG: MVT-2163

  • MVT-2163 is administered intravenously as a PET imaging agent.

DRUG: MVT-5873

  • MVT-5873 will be administered intravenously over at least 60 minutes.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of subjects with treatment-related adverse events as assessedassessed by CTCAE v4.01 year
Biodistribution of MVT-2163will be determined by measuring radiation exposure for key organs and tissues1 year
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:
    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)

Collaborators and Investigators

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

  • BioNTech SE
  • PRINCIPAL_INVESTIGATOR: Neeta Pandit-Taskar, 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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