Status:
COMPLETED
Study of a New Technique for Imaging Pancreatic Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
BioNTech SE
Conditions:
Pancreatic Cancer
Tumors That Express CA19-9
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04883775
Start Date
May 10 2021
End Date
January 27 2025
Last Update
January 30 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, United States, 11725