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

• Status: Terminated
• Trial end date: 2017-05-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNTech Research & Development, Inc.; MabVax Therapeutics, Inc.
• Collaborator: SciQuus Oncology

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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