NANOBIOTIX announced completion of the dose escalation part of a phase 1 dose escalation and dose expansion study evaluating potential first-in-class radioenhancer NBTXR3 for patients with locally advanced (LA) or borderline resectable (BR) pancreatic cancer (PC). The phase 1 study is being conducted by The University of Texas MD Anderson Cancer Center (MD Anderson). Study 2019-1001 is being conducted as part of the ongoing strategic collaboration between Nanobiotix and MD Anderson.

The complete dose escalation part of the study recruited 11 patients, and all patients had unresectable disease at study entry. A single intratumoral injection of NBTXR3 followed by 15 fractions of RT showed to be feasible and well-tolerated and the recommended phase 2 dose of NBTXR3 was established at 42% of gross tumor volume. Notably, one patient on Study 2019-1001 had a partial response 9 months after RT and has had durable local control for over two years.

One other patient experienced local control that allowed unresectable disease to become resectable. Negative margin surgery was achieved for this patient and pathological complete response was observed. The dose expansion part of the study will include more robust evaluation of patients with borderline resectable disease at study entry.