The trial, co-developed by Nanobiotix and MD Anderson, is set to evaluate the safety and feasibility of NBTXR3 activated-by-radiation therapy for patients with locally advanced (LAPC) or borderline resectable (BRPC) cases of pancreatic ductal adenocarcinoma (PDAC).
NBTXR3 is designed to destroy tumors through physical cell death when activated by radiotherapy. It has a high degree of biocompatibility, requires one administration before the first radiotherapy session and fits into current worldwide radiation therapy standards of care.
Nanobiotix touts the trial as the first to evaluate NBTXR3 activated-by-radiation therapy in pancreatic cancer, according to a news release.
The open-label, single-arm, prospective Phase I study includes a dose escalation to determine the recommended Phase II dose, followed by expansion at RP2D (the highest dose with acceptable toxicity). It will study adults over 18 years old with BRPC or LAPC that are radiographically non-metastatic at screening and have not previously received radiation therapy or surgery for pancreatic cancer.
Up to 24 subjects will be enrolled as Nanobiotix plans for an 18-month enrollment period with the first injection coming in the summer of 2020. Objectives include determining dose-limiting toxicity, the maximum tolerated dose and the RP2D.