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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence, Rhode Island, United States
Incidence of treatment related toxicities grade ≥3
Part 1 \| Safert: The primary endpoint is grade 3 or higher ASP-1929 photoimmunotherapy treatment related toxicity within 28 days of surgery.
Time frame: From start of treatment to 28 days post surgery
Number of Participants Reaching 6 Months Progression Free Survival
Part 2 (expansion cohort for efficacy): The primary endpoint of this cohort is 6-month progression free survival. RECIST version 1.1 will be used to assess for response/progression
Time frame: From start of treatment to 6 months post surgery.
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