Following the success of the Phase 1 NANORAD1 protocol, NHTherAguix launched two Phase 2 trials on brain metastasis using either panencephalic irradiation (NANORAD2) or stereoradio-surgery (NANOSTEREO) .
NANORAD2 is currently recruiting: click clinicaltrials.gov
NANORAD Phase1b trial : results
The First In Human phase 1 clinical trial NANORAD1 was conducted by the CHU of Grenoble Alps (principal investigator : Dr Camille Verry) on 15 patients with four types of brain metastases (melanoma, lung, colon, and breast). They received a single intravenous administration of Gd-based AGuIX nanoparticles while undergoing whole brain radiotherapy received (NANO-RAD, NCT02820454).
- No adverse effects were observed at the highest dose of 100 mg/kg, and AGuIX has a short blood half-life and selective tumor accumulation based on MRI observations.
- Magnetic Resonance Imaging : The nanoparticles were found to accumulate and to increase image contrast in all types of brain metastases with MRI enhancements equivalent to that of a clinically used contrast agent. The presence of nanoparticles in
metastases was monitored and quantified with MRI and was noticed up to 1 week after their administration (see publication about MRI results).
- Radiosensitizing effect : The individual analysis of MRI data for each of the 255 metastases in our 15 patients showed a significant correlation between contrast enhancement in metastases upon intravenous injection of AGuIX nanoparticles and tumor response (either a reduction in or stabilization of tumor volume), thus suggesting a radiosensitizing effect.