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.
Pathologically confirmed pancreatic adenocarcinoma.
Clinically staged locally advanced or borderline resectable pancreatic adenocarcinoma.
Completed neoadjuvant chemotherapy
Neoadjuvant radiation is allowed
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.
Single group
ASP-1929 photoimmunotherapy
Combination productApproximately 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.
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.
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
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Brown University
Lead sponsor
Rakuten Medical, Inc.
Collaborator
Rhode Island Hospital
Collaborator
The Miriam Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
