Efficacy and Safety of BC-819 and Gemcitabine in Patients With Locally Advanced Pancreatic Adenocarcinoma

Inclusion Criteria

• •1. Males or females \> 18 years of age
• •2. If female, must not be pregnant or nursing; women of child-bearing potential must practice a medically approved method of contraception
• •3. If male, must practice a medically approved method of contraception if have a partner of childbearing potential
• •4. Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
• •5. Locally advanced pancreatic cancer (LAPC) that is clinically unresectable as defined in the NCCN Guidelines
• •6. Karnofsky performance status (KPS) ≥ 70% at baseline
• •7. Adequate hematological, renal, and hepatic function
• •* Platelet count ≥ 100,000/mm3
• •* Absolute neutrophil count (ANC) ≥ 1500/mm3
• •* Hemoglobin ≥ 10.0 g/dL (may be achieved by transfusion)
• •* Creatinine (≤ 1.5 x ULN)
• •* ALT, AST (≤ 1.5 x ULN)
• •* Total Bilirubin (≤ 1.5 x ULN)
• •8. Have a target tumor lesion in the pancreas ≤ 6 cm in diameter that is accessible for intratumoral administration by EUS guidance as determined by the physician performing the EUS injection
• •9. Have a biopsy specimen that is positive for H19 expression (grade 2 or greater staining determined by a pathologist). H19 expression can be determined based on a biopsy specimen collected before study participation, if available.
• •10. No prior diagnosis of malignancy within 3 years except for curatively treated non-melanoma skin or in situ malignancies
• •11. Able to comply with the protocol procedures
• •12. Able and willing to provide written (signed) Informed Consent to participate in the study