The trial will enrol increased-risk, chemotherapy-ineligible elderly LA-HNSCC patients who are not eligible to receive platinum-based chemotherapy. Credit: KGH / commons.wikimedia.org.

Nanobiotix and LianBio have randomised the first subject in Asia in the global Phase III NANORAY-312 clinical trial of NBTXR3 to treat elderly individuals with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

The registrational, two-arm, randomised, investigator’s choice trial will evaluate the safety and efficacy of radiotherapy-activated NBTXR3 with or without cetuximab, compared to radiotherapy with or without cetuximab.

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The trial will enrol increased-risk elderly LA-HNSCC patients who are not eligible to receive platinum-based chemotherapy.

Trial subjects who have received a radiotherapy of the investigator’s choice alone, or radiotherapy plus cetuximab will be categorised into a 1:1 ratio to receive NBTXR3.

The company anticipates enrolling 500 subjects into the trial across the globe, with nearly 100 participants planned to be enrolled in licenced territories of LianBio taking part in the trial.

A new oncology product, NBTXR3 comprises functionalised hafnium oxide nanoparticles administered through a single intratumoral injection and activated using radiotherapy.

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In Greater China, Singapore, Thailand, and South Korea, LianBio has the exclusive rights for NBTXR3 development and marketing.

The latest trial is based on data from the Phase I Study 102 trial which assessed the safety and initial efficacy signs of radiotherapy-activated NBTXR3 in high-risk elderly patients with LA-HNSCC who are ineligible for chemotherapy and not tolerant to cetuximab.

LianBio CEO Yizhe Wang said: “We believe NBTXR3 has demonstrated the potential to improve treatment outcomes in multiple solid tumour indications, including in Study 102, the Nanobiotix Phase I trial evaluating the product candidate for the treatment of elderly patients with locally advanced head and neck squamous cell carcinoma.

“We look forward to working with our clinical partners at sites across Greater China and South Korea to evaluate NBTXR3 in this difficult-to-treat patient population.”