BetaGlue Therapeutics has secured Italian Ministry of Health approval for a clinical investigation of YntraDose in unresectable locally advanced pancreatic ductal adenocarcinoma, following an earlier greenlight from the UK’s MHRA. The early feasibility study is slated to start enrollment in early 2026 with preliminary data targeted for year-end, focused on safety, procedural usability, and feasibility.
The device-based therapy delivers locoregional radiotherapy via percutaneous injection of Yttrium-90 microspheres embedded in a fast-polymerizing matrix designed to immobilize the isotope within the tumor. The approach aims to localize dose to pancreatic lesions while limiting non-target exposure, an operational challenge that has constrained adoption of other pancreatic ablative modalities. The trial will initially run at Gemelli IRCCS in Rome, with plans for international expansion contingent on feasibility outcomes.
Strategically, BetaGlue is positioning a device-driven radiotherapeutic in a space where systemic regimens have plateaued and interest in local control is rising, particularly after induction chemotherapy in non-metastatic disease. The concept echoes radioembolization logic while shifting from intra-arterial delivery to direct intratumoral placement. The differentiator is the polymer matrix intended to reduce microsphere migration, a critical risk when placing Y-90 outside vascular territories. With approvals in both Italy and the UK, the company is setting up a cross-border, ISO 14155-governed clinical path under divergent but converging European and UK device oversight, before attempting a larger efficacy program.
For sites, the operational footprint is nontrivial. Interventional radiology, nuclear medicine, and radiation safety will need tight integration for Y-90 procurement, hot-lab handling, chain-of-custody, and waste management within short half-life logistics. Credentialing for percutaneous pancreatic access and management of potential pancreatitis or vascular complications will be central to start-up readiness and monitoring plans. Imaging protocols to confirm on-target deposition and dose distribution—whether via Y-90 PET/CT or Bremsstrahlung-based methods—will influence both safety adjudication and any early signals of activity. Given an initial single-site start, enrollment cadence and reproducibility across operators will be early pressure points.
For CROs and vendors, the study demands device trial expertise plus radiation compliance infrastructure, human factors and usability data capture, and real-time procedural documentation. Manufacturing coordination around Y-90 availability, kit assembly, and site delivery windows will test supply reliability. Sponsors and regulators will be watching for procedural success rate, containment of radioactivity, rates of grade 3 or higher adverse events, and any early signs of local control or conversion to resectability, which—while not primary endpoints—will shape the pivotal design and justification under EU MDR and UK pathways.
The next six to twelve months should clarify protocol details that determine scalability: sequencing with systemic therapy, lesion size constraints, single versus multiple injections, dosimetry methodology, and site expansion beyond Italy. Key risks include slow activation due to radioprotection approvals, a steep learning curve in the pancreas, and limited tolerance for off-target effects in a frail population. If feasibility metrics are clean and logistics prove manageable, a multicenter EU/UK expansion and eventual U.S. early feasibility filing would be logical steps. The marker to watch is whether the platform can consistently deliver controlled intratumoral dose with acceptable morbidity—without that, the commercial and regulatory path will remain narrow despite the clear unmet need.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
