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news.AFSSAPS, the French medicine agency, has allowed Nanobiotix to begin an open-label, single arm, prospective, dose-escalation,, non-randomized Phase I trial to evaluate NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment).
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In the trial, NBTXR3 will be given to the patients before surgery by a single intra-tumoral injection followed by standard radiotherapy procedure.
The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety.
Nanobiotix CEO and co-founder Laurent Levy said developed in close collaboration with leading oncologists and radiotherapists, NBTXR3 is the first product from their NanoXray pipeline to enter clinical development.