BrUOG 438: EGFR Targeted Photoimmunotherapy With ASP-1929 for Locally Advanced Pancreatic Cancer
Brown University
Summary
This is an open label phase II study to determine the safety and preliminary efficacy of photoimmunotherapy (PIT) for patients with locally advanced and borderline resectable pancreatic cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically confirmed pancreatic adenocarcinoma. 2. Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma. 3. Completed neoadjuvant chemotherapy 4. Neoadjuvant radiation is allowed 5. Planned surgical exploration 6. Treatment with ASP-1929 will be at least 4 - 10 weeks after last chemotherapy and radiation. 7. Patients with a history of biliary obstruction must have adequate biliary drainage. 8. Patients meeting the following laboratory criteria for Adequate Organ and Bone Marrow Function: Platelet Count ≥ 75,000/mm3. Hemoglobin ≥…
Interventions
- Combination ProductASP-1929 photoimmunotherapy
Approximately 24 hours prior to surgery, patients will receive ASP-1929, IV over 2 hours, in the outpatient clinic. ASP-1929 is an EGFR targeting antibody conjugated with a laser-light activable dye IR700 (IRDye 700DX). The following day patients will undergo standard surgical exploration. Those patients found to be inoperable on surgical exploration will be treated with the laser device (Alluminox platform) over 5 minutes in the operating room to activate ASP-1929 photoimmunotherapy. Activation of the IR700 dye with red light (690nm) may result in anticancer activity mediated by immunogenic cell death and necrosis, leading to activation of the immune system.
Location
- Rhode Island and the Miriam Hospitals (Brown University Health)Providence, Rhode Island