The Phase II NANOBRAINMETS trial of AGuIX has been validated by the Data Safety and Monitoring Board (DSMB) following a futility analysis scheduled after the enrolment and follow-up of 50% of patients in the study. 

The trial is being run by NH TherAguix, a biotechnology company developing novel nanomedicine solutions for precision radiotherapy in oncology, and is managed by the Dana Farber Cancer Institute.

Ongoing evaluation of the study has revealed no serious adverse events related to the administration of AGuIX, highlighting the favourable safety profile of this drug candidate. AGuIX is designed to improve tumour targeting and increase radiobiological damage to tumour tissue locally, due to its radiation signal amplification capabilities. 

A total of 96 patients have been randomised to date of the 134 scheduled in the study’s protocol. 

NANOBRAINMETS trial

NANOBRAINMETS is a randomised, double-blind Phase II trial evaluating AGuIX in combination with stereotactic radiotherapy in patients with brain metastases, compared with a control arm using stereotactic radiotherapy alone. The next interim analysis is currently expected by the end of this year to assess the clinical efficacy of AGuIX. 

Dr Ayal Aizer, Director of the Central Nervous System Radiation Oncology Division at the Brigham and Women’s Hospital / Dana-Farber Cancer Institute, and Principal Investigator of the NANOBRAINMETS study, said: “We are very pleased to continue this cutting-edge clinical trial, which evaluates a promising new treatment for patients suffering from brain metastases. This study could lead to the development of a new standard of treatment for these devastating cancers, addressing a significant medical need today.” 

Vincent Carrère, CEO of NH TherAguix, added: “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.” 

Megan Thomas, Multimedia Editor, DDW