EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer

Inclusion criteria

• Pathologically confirmed pancreatic adenocarcinoma.
• Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
• Completed neoadjuvant chemotherapy
• Neoadjuvant radiation is allowed
• Planned surgical exploration
• Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation.
• Patients with a history of biliary obstruction must have adequate biliary drainage.
• Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function:

Platelet Count ≥ 75,000/mm3. Hemoglobin ≥ 8.0 g/dL [NOTE: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible] Absolute neutrophil count ≥ 1,000/mm3. [Granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1] Alanine aminotransferase (ALT) ≤ 3×ULN Aspartate aminotransferase (AST) ≤ 3×ULN Total Bilirubin ≤ 1.5×ULN or < 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) Creatinine ≤ 3×ULN

• Age ≥ 18
• ECOG performance status 0-1
• For women of pregnancy potential, a negative pregnancy test within 7 days prior to registration.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Patients with distant metastases.
• Patients with medical co-morbidities that make them not candidates for surgical exploration
• Planned concomitant, non-protocol directed anti-cancer therapy for at least 8 weeks after ASP-1929
• Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2.
• History of significant (Grade ≥ 3) cetuximab infusion reactions
• Photosensitizing medications must be discontinued 4 weeks before ASP-1929 PIT treatment, unless medically required.
• No uncontrolled intercurrent illness including but not limited to symptomatic CHF, unstable angina, clinically significant severe cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with study requirements.
• Any other condition which, in the investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to PIT illumination.
• Women who are pregnant or nursing.
• Patients with concomitant malignancies not expected to cause death within 5 years are eligible.