On September 18, 2023 NH TherAguix ("NHT"), a research-based biotech company specialized in the development of innovative nanomedicines for the treatment of cancer by radiotherapy, and Jean PERRIN Cancer Center in Clermont-Ferrand reported the completion of phase I recruitment and the entry into Phase II for the Nano-GBM phase I/II trial in newly diagnosed glioblastoma, sponsored by Jean PERRIN Cancer Center and led by Pr Julian Biau, radiation oncologist.
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This phase I/II clinical trial investigates the tolerance and efficacy of the combination of AGuIX intravenous injections with radiotherapy plus concomitant temozolomide in the treatment of newly diagnosed glioblastoma.
Nano-GBM is a multicentric, randomized, open-label and non-comparative Phase I/II trial. The aim of the dose escalation phase I was to determine the recommended dose of experimental drug to be evaluated for the phase II. 3 dose levels of AGuIX (50mg/kg, 75mg/kg and 100mg/kg) have been tested on eight patients treated in Phase I. These patients with unresected or partially resected glioblastoma have received four injections of AGuIX in combination with temozolomide (75 mg/m²/day) and radiotherapy (60 Gy in 30 fractions of 2 Gy), followed by adjuvant temozolomide according to Stupp protocol, as the standard of care. AGuIX injections were well-tolerated. In addition, MRI analysis has confirmed that AGuIX nanoparticles selectively accumulated in glioblastoma. The Data Safety Monitoring Board, an independent group of experts external to the trial, has confirmed the safety profile of AGuIX in combination with chemo-radiotherapy for the treatment of glioblastoma patients, has validated the recommended dose chosen as well as the continuation of the trial into Phase II.
Pr. Julian Biau stated: "We are happy to have successfully completed the phase I at Jean PERRIN Cancer Center. Based on a favorable safety profile of AGuIX in combination with Stupp protocol, we are encouraged to pursue assessment of this nanoparticle efficacy within the phase II of this innovative clinical trial, in collaboration with other investigator centers".
Dr. Olivier de Beaumont, CMO of NHT said: "After first hints of efficacy in brain metastases indication, NHT is pursuing further the clinical assessment of AGuIX in neuro-oncology. Based on a robust scientific package demonstrating efficacy of AGuIX in rodents with glioblastoma, this phase I/II clinical trial was designed with the objective to demonstrate the safety and efficacy of AGuIX in patients with glioblastoma de novo. With the completion of the phase I of the Nano-GBM study, we are confirming the good tolerance of AGuIX administered at 100mg/kg via intravenous infusions and we are extremely proud to enter the phase II randomized part of the study with the objective to show a patient clinical benefit in combination with Stupp protocol as standard of care".
This phase II study will be randomized with two arms: an experimental arm in which patients will be treated with AGuIX at a dose of 100 mg/kg in combination with radio-chemotherapy (40 patients), and a control arm in which patients will be treated with radio-chemotherapy alone (20 patients). To date, the two first patients of the phase II have been included in the control arm.
The primary endpoint of this phase II study is progression-free survival at 6 months. Secondary endpoints include AGuIX distribution in tumors, progression-free survival, overall survival, overall objective response rate and the safety profile of AGuIX in combination with radiotherapy and temozolomide.