AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

Summary

This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method. Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

Timeline

Start

2018-05-17

Primary completion

2022-07

Completion

2024-05

Publications

• Maury P, Mondini M, Chargari C, Darricau A, Shahin M, Ammari S, Bockel S, Genestie C, Wu TD, Lux F, Tillement O, Lacombe S, Deutsch E, Robert C, Porcel E. Clinical transfer of AGuIX(R)-based radiation treatments for locally advanced cervical cancer: MR quantification and in vitro insights in the NANOCOL clinical trial framework. Nanomedicine. 2023 Jun;50:102676. doi: 10.1016/j.nano.2023.102676. Epub 2023 Apr 20.

Drugs

Indications