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Phase I/II study testing the combination of AGuIX nanoparticles with radiochemotherapy and concomitant temozolomide in patients with newly diagnosed glioblastoma (NANO-GBM trial protocol)
Open accessAbstract
Background: Despite standard treatments including chemoradiotherapy with temozolomide (TMZ) (STUPP protocol), the prognosis of glioblastoma patients remains poor. AGuIX nanoparticles have a high radiosensitizing potential, a selective and long-lasting accumulation in tumors and a rapid renal elimination. Their therapeutic effect has been proven in vivo on several tumor models, including glioblastoma with a potential synergetic effect when combined with TMZ based chemoradiotherapy, and they are currently evaluated in 4 ongoing Phase Ib and II clinical trials in 4 indications (brain metastases, lung, pancreatic and cervix cancers) (> 100 patients received AGuIX). Thus, they could offer new perspectives for patients with newly diagnosed glioblastoma. The aim of this study is to determine the recommended dose of AGuIX as a radiosensitizer in combination with radiotherapy and TMZ during the concurrent radio-chemotherapy period for phase II (RP2D) and to estimate the efficacy of the combination. Methods: NANO-GBM is a multicenter, phase I/II, randomized, open-label, non-comparative, therapeutic trial. According to a dose escalation scheme driven by a TITE-CRM design, 3 dose levels of AGuIX (50, 75 and 100 mg/kg) will be tested in phase I added to standard concomitant radio-chemotherapy. Patients with grade IV glioblastoma, not operated or partially operated, with a KPS ≥ 70% will be eligible for the study. The primary endpoints are i) for phase I, the RP2D of AGuIX, with DLT defined as any grade 3–4 NCI-CTCAE toxicity and ii) for phase II, the 6-month progression-free survival rate. The pharmacokinetics, distribution of nanoparticles, tolerance of the combination, neurological status, overall survival (median, 6-month and 12-month rates), response to treatment, and progression-free survival (median and 12-month rates) will be assessed as secondary objectives. Maximum sixty-six patients are expected to be recruited in the study from 6 sites. Discussion: The use of AGuIX nanoparticles could allow to overpass the radioresistance to the reference treatment of newly diagnosed glioblastomas that have the poorest prognosis (incomplete resection or biopsy only). Trial registration: Clinicaltrials.gov: NCT04881032 , registered on April 30, 2021. Identifier with the French National Agency for the Safety of Medicines and Health Products (ANSM): N°Eudra CT 2020-004552-15. Protocol: version 3, 23 May 2022.
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Gadolinium-based nanoparticles such as AGuIX have progressed into clinical trials, particularly in brain metastases and other indications, demonstrating feasibility, imaging capability, and preliminary therapeutic benefit.
“Similarly, gadolinium-based nanoparticles such as AGuIX have progressed into clinical trials, particularly in brain metastases and other indications, demonstrating feasibility, imaging capability, and preliminary therapeutic benefit [114,115,116,117].”
From Nanoparticle-Mediated Radiosensitization in Breast Cancer: A Systematic Review of Preclinical Evidence and Translational Challenges (2026) · cites this paper as [117]
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Liu, J., Zhao, L., Sun, Y., Fu, Q., & Xiao, W. (2025) · Materials Today Bio · doi:10.1016/j.mtbio.2025.102186 · Cited by 9
“In clinical trials, the combination of AGuIX ® and MRI - guided radiotherapy has been successfully utilized in the treatment of brain tumors [192], glioblastoma [193], and cervical cancer [194], indicating promising application prospects.”
Lunca, S., Morarasu, S., & Dimofte, G. M. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27146522 · Cited by 2
“Similarly, gadolinium-based nanoparticles such as AGuIX have progressed into clinical trials, particularly in brain metastases and other indications, demonstrating feasibility, imaging capability, and preliminary therapeutic benefit [114–117].”
Metadata
- Authors
- Thivat, E., Casile, M., Moreau, J., Molnar, I., Dufort, S., Seddik, K., Le Duc, G., De Beaumont, O., Loeffler, M., Durando, X., & Biau, J.
- Affiliations
- Inserm (FR)
- Venue
- BMC Cancer
- Published
- 2023-04-15
- Volume
- 23
- Issue
- 1
- Pages
- 344-344
- ISSN
- 1471-2407 (ISSN-L)
- PMC
- PMC10105392
- OpenAlex
- W4365503342
- Cited by
- 76
- References
- 18
- Citations by year
- 2026: 25 · 2025: 27 · 2024: 20 · 2023: 4
- FWCI
- 13.12
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Cancer (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Ligue Contre le Cancer
- Topics
- Health Sciences › Medicine › Oncology › Glioma Diagnosis and Treatment
- Physical Sciences › Physics and Astronomy › Radiation › Radiation Therapy and Dosimetry
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Radiopharmaceutical Chemistry and Applications
- Keywords
- glioblastoma, radiosensitization, temozolomide, chemoradiotherapy, concurrent chemoradiotherapy, recommended phase 2 dose, dose-limiting toxicity, radioresistance (biology), nanoparticle drug delivery, progression-free survival, pharmacokinetics, dose escalation, newly diagnosed glioblastoma
- MeSH terms
- Temozolomide, Brain Neoplasms, Female, Gadolinium, Glioblastoma, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Antineoplastic Agents, Alkylating, Nanoparticles, Chemoradiotherapy
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