The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.
Single center, open label, escalating dosage of PCX12 with standard of care practice for subjects who are diagnosed with adenocarcinoma of the head of the pancreas. Subjects with undergo standard of care radiation therapy and then start on PCX12 therapy starting at 200 ng/kg of PCX12 escalating to a potential maximum dosage of 800 ng/kg of PCX12 with adjacent tolerability and safety guidelines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
treatment combining radiation therapy with PCX12
University of Rochester
Rochester, New York, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
The Primary objective of the safety lead in component is to report acute, attributable, gastrointestinal toxicity
Time frame: 3 years
Maximum tolerable dose [Safety and Tolerability]
Maximum tolerable dose is defined by less than or equal to 30% dose limiting toxicity (DLT) event rate within a given dose
Time frame: 3 years
Rate of radiographic response
This study will assess radiographic response following SBRT and PCX12 utilizing RECIST 1.1 criteria
Time frame: 2 months
Change in biomarkers of innate and adaptive immunity
A combination of flow/mass cytometry will be employed to assess intratumoral immune cells before and after treatment. Specifically, cells of the adaptive immune system, namely B and T cells (both CD4+ and CD8+), along with innate cells including monocytes, macrophages, neutrophils, and natural killer cells will be investigated and percent of total CD45+ cells along with absolute cell number will be tabulated. Additionally, markers of activation (IFNg, TNF, etc.) along with suppression (PD1, PD-L1, LAG3, etc.) will be included in the panel of analysis.
Time frame: baseline and 4 weeks
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