The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and neck squamous cell carcinoma or with metastatic non-small cell lung cancer.
The company plans to enroll between 36 and 72 patients in Phase I and 40 patients in the second phase.
“The FDA’s approval of Nanobiotix’s IND application for this trial is a major milestone for our company,” CEO Laurent Levy said in prepared remarks.
“We’re ready and excited to launch our first immuno-oncology clinical trial in the U.S. combining NBTXR3 with a checkpoint inhibitor. Advancing our demonstration of NBTXR3’s potential to turn checkpoint inhibitor non-responders into responders could be game-changing, and the approach could address the unmet medical needs of a significant number of patients. Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology.”
Top-line data from the trial is expected in mid-2019, Nanobiotix reported.