Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

Stopped early · Phase 1

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

In brief

Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.

Key facts

Study ID

NCT02687230

Run by

BioNTech Research & Development, Inc.

People needed

15

Starts

2016-07-11

Expected to finish

2017-05-05

Last updated by the study team

2021-08-31

Who can join

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

You may qualify if…

• Signed, informed consent
• Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
• At least one lesion by CT or MRI ≥ 2 cm
• ECOG performance status of 0 to 2
• Absolute neutrophil count ≥1.50 x 109/L
• Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14 days)
• Platelet count >75,000/ mm3
• 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
• Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min
• Serum albumin > 3.0g/dL
• Willingness to participate in collection of pharmacokinetic samples
• Willingness to use adequate contraception throughout study and for a period of 90 days last dose of study drug

You may not qualify if…

• Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
• Major surgery other than diagnostic surgery within 28 days
• History of anaphylactic reaction to human, or humanized, antibody
• Other on-going cancer therapy or investigational agents (except MVT-5873 )
• Known history of HIV or Hepatitis C
• Pregnant or currently breast-feeding
• Psychiatric illness/social situations that would interfere with compliance with study requirements
• Significant cardiovascular risk including, but not limited to, recent (within 28 days) coronary stenting or myocardial infarction within 6 months

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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