Nanomedicine company Nanobiotix has received authorization from the French Medicine Agency to start clinical trials for its drug, NBTXR3, on patients with locally advanced cancers of the oral cavity or oropharynx.
It is the second indication for NBTXR3, which is also in clinical trials for soft-tissue sarcoma, the company noted in a press release. The phase I trial will be an open-label nonrandomized, dose escalation study of safety and tolerability evaluation of NBTXR3, and will be conducted at the Institut Curie, Paris, a cancer treatment center.
The product will be implanted by intra-arterial (IA) or intratumor (IT) injection, and activated by intensity-modulated radiation therapy (IMRT).
Two different administration schedules of NBTXR3 will be investigated simultaneously in two different groups of patients. Based on the observed safety, the recommended doses for further evaluation of NBTXR3 as intra-arterial or intratumor injection with radiotherapy will be selected.
The study will also assess of the tumor response rate and complete response rate by MRI, and the evaluation of local and general progression free survival of NBTXR3. Furthermore, the feasibility of local administration, either intratumor or intra-arterial injection of NBTXR3, then activated by radiotherapy will be evaluated.
Approximately 48 patients are expected to take part in the trial.
