Pancreatic Cancer, Tumors That Express CA19-9
Conditions
Keywords
89Zr-DFO-HuMab-5B1 (MVT-2163), Imaging, MVT-5873, 20-342
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 better images of cancer.
Interventions
Sponsors
BioNTech SE
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a phase I, open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 (89Zr-DFO-HuMab-5B1) and varying antibody masses of MVT-5873 (HuMab-5B1), designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging. This trial will include dose escalation, which includes up to 5 cohorts, an expansion phase, a re-entry phase, and a pre-surgery phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with treatment-related adverse events as assessed | 1 year | assessed by CTCAE v4.0 |
| Biodistribution of MVT-2163 | 1 year | will be determined by measuring radiation exposure for key organs and tissues |
Countries
United States
Outcome results
None listed