Nanobiotix announced that the first participant has been randomised in the US in the global Phase III NANORAY-312 trial of NBTXR3 to treat locally advanced head and neck squamous cell carcinoma (LA-HSNCC) in elderly patients.

The Phase III registrational trial has been designed for evaluating the safety and efficacy of radiotherapy-activated NBTXR3 alone or in combination with cetuximab against radiotherapy alone or along with cetuximab in LA-HSNCC elderly patients who are at high-risk and are ineligible for platinum-based chemotherapy.

Up to 500 participants are expected to be enrolled globally in the trial, with Asia, Europe, and the US as the major regions.

The randomised, two-arm, global, investigator’s choice NANORAY-312 is being conducted in collaboration with LianBio, said Nanobiotix.

Following an Investigator’s Choice of radiotherapy alone or along with cetuximab, all the eligible study participants will be treated with NBTXR3 at a 1:1 ratio.

In the NANORAY-312 study, Nanobiotix randomised the first participant in Europe in January this year and LianBio randomised the first patient in Asia in August.

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Nanobiotix co-founder and executive board chairman Laurent Levy said: “Our pivotal, global Phase III NANORAY-312 trial for lead candidate NBTXR3 continues to build momentum with sites now active in the United States, Europe, and Asia.

“NANORAY-312 is the first of our prioritised registrational trials in head and neck cancer and is designed to prove that our innovation can make a difference for elderly patients around the world, a growing patient population with high unmet medical need.

“We believe data on survival and anti-tumoral response in our proof-of-concept Phase I Study 102 continue to support the potential of NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly patients with head and neck cancer and we look forward to reporting additional milestones from our head and neck cancer franchise studies in 2023.”

The company stated that the trial now has 80 sites activated across the world.

It expects to receive the Phase III futility analysis in the first half of next year and the interim data is expected in the second half of 2024.