Washington University School of Medicine
The investigators hypothesize that CD11b agonism reprograms the tumor microenvironment (TME) to overcome resistance to checkpoint immunotherapy in pancreatic ductal adenocarcinoma (PDAC). Therefore, the investigators propose an open label phase I/II clinical trial of ONT01 with gemcitabine and nab-paclitaxel in unresectable pancreatic ductal adenocarcinoma prior to future studies incorporating anti-PD1 checkpoint immunotherapy.
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the pancreas. * Measurable or evaluable disease per RECIST 1.1. * Previously treated with first-line systemic therapy for unresectable/advanced or metastatic PDAC and experienced progression or became intolerant to the therapy and is in need of another line of systemic therapy in the opinion of the investigator. * At least 18 years of age. * ECOG performance status ≤ 1. * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobi…
Per assigned dose level.
The dose of gemcitabine is 1000 mg/m\^2.
The dose of nab-paclitaxel is 125 mg/m\^2.
Arctuva estimate
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