The trial is assessing AGuIX plus stereotactic radiotherapy in patients with brain metastases. Credit: peterschreiber.media/Shutterstock.

NH TherAguix (NHT) has announced that it has received validation from the Data Safety Monitoring Board (DSMB) for continuing the Phase II NANOBRAINMETS trial of AGuIX to treat patients with brain metastases.

This development comes after the board reviewed the data from the futility analysis that was carried out following the enrolment and follow-up of 50% of subjects in the trial.

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Managed by the Dana Farber Cancer Institute, the randomised, double-blind trial is assessing AGuIX plus stereotactic radiotherapy versus stereotactic radiotherapy alone in patients with brain metastases.

As per the latest data, AGuIX was demonstrated to have a favourable safety profile, without any serious adverse events reported.

To date, 96 out of the 134 planned patients have been randomised in the study.

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An interim analysis to assess clinical efficacy is anticipated to be conducted by the end of this year.

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AGuIX is developed by NHT and aims to enhance tumour targeting while also increasing radiobiological damage to tumour tissues locally.

A nanodrug, AGuIX contains a high concentration of gadolinium atoms within an ultrasmall structure.

The asset is currently under evaluation in several Phase II randomised trials for different cancers, such as brain metastases and glioblastoma, as well as pancreatic and lung cancers.

More than 200 patients have so far received treatment with AGuIX, demonstrating a safety profile and encouraging preliminary clinical outcomes.

NH TherAguix CEO Vincent Carrère said: “This first positive step paves the way for the major next inflexion point expected in the second half of the year regarding the interim efficacy analysis of AGuIX.

“The Phase II final results expected by Q2-Q3 2026 will be decisive for the further clinical development of AGuIX and its commercial approval for treating these cancers with high medical need.”