Study of a New Technique for Imaging Pancreatic Cancer

Completed · Phase 1

Conditions studied: Pancreatic Cancer, Tumors That Express CA19-9

In brief

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.

Key facts

Study ID

NCT04883775

Run by

Memorial Sloan Kettering Cancer Center

People needed

4

Starts

2021-05-10

Expected to finish

2025-01-27

Last updated by the study team

2025-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent only ) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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