The objective of this study is to investigate whether adding the study drug, NP137, to a patient's treatment regimen (before surgery and in combination with chemotherapy afterward) can alter the behavior of pancreatic cancer..
The aim of this study is to evaluate the mechanism of action for a novel anti-Netrin-1 antibody (NP137) in patients with pancreatic ductal adenocarcinoma. Pre-clinical data indicates that anti-Netrin-1 therapy can prevent/delay metastatic progression of disease by inducing cancer cell death through its dependence receptor Unc5b as well as prevent epithelial to mesenchymal transition (EMT). This pilot study is designed to provide vital translational scientific information that will inform the design of future clinical trials for NP137. This information includes determining the optimal use of NP137 with cytotoxic, as well as the treatment setting of resectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
NP137 for the Treatment of Resectable Pancreatic Cancer
University of Rochester
Rochester, New York, United States
Determining if NP137 can shift the primary tumor MAK's Signature Epithelial-to-Mesenchymal Transition (EMT) Mean Score towards a more epithelial phenotype
EMT score is determined by the mean expression of mesenchymal genes minus the mean expression of epithelial genes Therefore, a positive EMT score suggests a mesenchymal status (worse outcome), whereas a negative score indicates an epithelial status (better outcome).
Time frame: 3-5 years
Pathological Response Rate
Pathologic response rate after treatment with NP137. The Pathological Response definition will follow the College of American Pathologists criteria
Time frame: 3-5 years
Two-year metastasis-free survival
Metastasis-free survival at two years. Metastasis-free survival is defined as the time between the date of enrollment and the date of the 1st distant event occurrence .
Time frame: 4-7 years
Disease free survival
Disease free survival defined as time from the date of enrollment until the date of the first cancer-related event, second cancer, or death from any cause.
Time frame: 5-8 years
Overall survival
Overall survival is defined by the date of enrollment to date of death from any cause
Time frame: 5-8 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Descriptive of Adverse event during the trial.
Time frame: 5-8 years
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