Nanobiotix announced the first patient in the United States has been randomized in NANORAY-312, a global Phase 3 registrational trial evaluating NBTXR3 for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy.
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NBTXR3 activated by radiotherapy will be evaluated alone or in combination with cetuximab. NBTXR3 is a potentially first-in-class radioenhancer with broad application across solid tumors, with prioritized focus in head and neck cancer.
NANORAY-312 is a global, two-arm, randomized, Investigator’s Choice Phase 3 registrational study that is designed to investigate the efficacy and safety of radiotherapy-activated NBTXR3 with or without cetuximab versus radiotherapy with or without cetuximab in high-risk, platinum-based chemotherapy-ineligible elderly patients with locally advanced head and neck squamous cell carcinoma (LA-HSNCC).
Eligible participants will be treated with NBTXR3 at a 1:1 ratio after an Investigator’s Choice of radiotherapy alone or radiotherapy in combination with cetuximab.
This pivotal trial is expected to enroll 500 patients globally, with the United States, Europe, and Asia as its major regions.
NANORAY-312 is co-led by principal investigators Sue Yom, MD, PhD, Professor and Vice Chair, Strategic Advisory Department of Radiation Oncology; Professor, Otolaryngology-Head and Neck Surgery at The University of California, San Francisco, and Christophe Le Tourneau, MD, PhD, senior medical oncologist and head of the Department of Drug Development and Innovation (D3i) at Institut Curie (Paris).
NANORAY-312 is being conducted in partnership with LianBio. LianBio is leading clinical development in Asia and holds exclusive rights to develop and commercialize NBTXR3 in Greater China, South Korea, Singapore and Thailand. Nanobiotix is leading clinical and commercial development in all other regions.
In 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.
Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, and Germany. ■