NBTXR3 Activated by Radiation Therapy for the Treatment of Locally Advanced or Borderline-Resectable Pancreatic Cancer

Eligibility Criteria

• 1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study 2. Age ≥ 18 years 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
• 1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
• 2. Age ≥ 18 years
• 3. Biopsy proven ductal adenocarcinoma of the pancreas,as defined by the following:
• 4. Has had a 4-month course (± 2-months) of chemotherapy for PDAC without radiographic evidence of distant metastatic disease. Following chemotherapy regimens are allowed:
• 1. gemcitabine/nab-paclitaxel
• 2. gemcitabine/capecitabine
• 3. gemcitabine/cisplatin
• 4. gemcitabine
• 5. FOLFOX
• 6. FOLFIRINOX
• 5. Amenable to undergo the endoscopic ultrasound guided injection of NBTXR3 as per investigator or treating physician.
• 6. Has a target lesion in the pancreas that is identifiable on cross sectional imaging by repeated measurements (via RECIST 1.1) at the same anatomical location
• 7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• 8. Laboratory Values at screening:
• 1. Hemoglobin ≥ 8.0 g/dL
• 2. Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
• 3. Platelet Count ≥ 100,000/mm3
• 4. Creatinine ≤ 1.5 x upper limit of normal (ULN)
• 5. Total Bilirubin ≤ 2.0 mg/dL
• 6. AST / ALT ≤ 3.0 x upper limit of normal (ULN)
• 7. Serum albumin ≥ 3.0 g/dL
• 9. Negative pregnancy test ≤ 7 days prior to NBTXR3 injection in all females of child-bearing potential
• 10. If participant has a history of prior duodenal or biliar plastic stent, it should be replaced with a metal stent ≥ 1 week prior to Study Day 1.
• 1. Prior radiation therapy to the upper abdomen
• 2. Prior surgical resection of pancreatic tumor
• 3. Diagnosis other than pancreatic ductal adenocarcinoma. All other histologic types (i.e., adenosquamous, cystadenocarcinoma, etc.) are not eligible to participate on this study.
• 4. LAPC or BRPC with radiographic evidence of distant metastasis at screening.
• 5. Has received any approved or investigational anti-neoplastic agent other than the chemotherapies specified in this protocol (i.e. chemotherapies included in Inclusion #4)
• 6. Known uncontrolled (Grade ≥ 2) or active gastric or duodenal ulcer disease within 30 days of enrollment
• 7. Known contraindication to iodine-based or gadolinium-based IV contrast
• 8. Active malignancy, in addition to pancreatic cancer, with the exception of basal cell carcinoma of the skin definitively treated and relapse free within at least 1 year from diagnosis
• 9. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second or third degree atrioventricular heart block without a permanent pacemaker in place)
• 10. Class III or IV Congestive Heart Failure as defined by the New York Heart Association functional classification system \<6 months prior to screening
• 11. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection
• 12. Female patients who are pregnant or breastfeeding
• 13. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \< 1% per year when used consistently and correctly
• 14. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments