(Boursier.com) — Nanobiotix announces that a first patient has been randomized in the United States in the NANORAY-312 trial, a global Phase 3 trial evaluating NBTXR3 in the treatment of elderly patients with locally advanced squamous cell carcinoma of the head and neck who are not eligible for platinum-based chemotherapy. NBTXR3 activated by radiotherapy will be evaluated alone or in combination with cetuximab. NBTXR3 is a potentially first-in-class radioenhancer with broad application in solid tumors, with priority given to head and neck cancer.
“Our international pivotal Phase 3 NANORAY-312 trial evaluating our lead product candidate, NBTXR3, reinforces its positive momentum: sites are now active in the United States, Europe and Asia”, said Laurent Levy, co-founder of Nanobiotix and Chairman of the Board. “NANORAY-312 is the first priority registration trial in head and neck cancer; it was designed to demonstrate that our innovation can make a difference for elderly patients worldwide, a patient population that continues to grow with a significant unmet medical need.We believe that the survival data and antitumor response from our Phase 1 “proof of concept” 102 study, continue to support the potential of NBTXR3 used alone and activated by radiotherapy in the treatment of elderly patients with head and neck cancer and we look forward to presenting the next steps in 2023 of our studies in head and neck cancer.”
The first patient in the NANORAY-312 study was randomized in Europe by Nanobiotix in January 2022, followed by the randomization of the first patient in Asia by LianBio, a strategic partner of Nanobiotix, in August 2022. The randomization of the first patient in the United Unis is concretely finalizing the implementation of the study planned by the Company across the main regions of the world in 2022.
Nanobiotix remains focused on conducting the clinical trial, building on the 80 sites currently activated; on patient recruitment; and on the preparation of the analyzes planned for 2023.
©2022 Boursier.com