Phase 2 ASP-1929 EGFR-targeted photoimmunotherapy (cetuximab–IR700 conjugate) in pancreatic cancer.

This open-label Phase 2 BrUOG 438 study tests ASP-1929 photoimmunotherapy (PIT) as a peri-operative, EGFR-targeted cytotoxic immune-activating approach for locally advanced or borderline resectable pancreatic adenocarcinoma after prior neoadjuvant chemotherapy and planned surgical exploration. ASP-1929 (also called cetuximab saratolacan) is an EGFR-directed monoclonal antibody conjugated to the light-activatable dye IR700; after IV dosing, 690 nm red light activation (Alluminox platform) is intended to trigger rapid, localized tumor-cell membrane damage with immunogenic cell death/necrosis. In the design described, patients receive ASP-1929 about 24 hours pre-op; those found inoperable at exploration receive intraoperative light activation, while resectable patients proceed to standard resection and have tumor assessed for EGFR receptor saturation. Brown University sponsors a 10-patient safety run-in followed by an expansion to evaluate preliminary efficacy (total planned ~30). Today’s care for borderline resectable/locally advanced PDAC commonly uses multi-agent neoadjuvant chemo (often modified FOLFIRINOX or gemcitabine/nab-paclitaxel) ± chemoradiation, with surgery only when disease becomes operable; this trial probes whether a surgery-adjacent, EGFR-targeted, device-enabled “local kill” can improve local control or convert tough intraoperative scenarios without adding broad systemic toxicity.