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Nanobiotix initiates trial of drug for liver metastasis and HCC
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The French National Agency for Medicines and Health Products has given Nanobiotix authorization to begin a clinical trial investigating its drug NBTXR3 for the treatment of liver metastasis and hepatocellular carcinoma, according to a press release.
The trial, which is a part of the nanomedicine Nano Innovation for CancEr consortium, will be multinational, nonrandomized, phase 1/2 studies evaluating the use of NBTXR3 with high doses of stereotatic body radiation therapy (SBRT), according to the release.
The goal is to introduce NBTXR3, a drug that is injected directly into a tumor, in combination with SBRT in patients with liver cancers who need an alternative treatment to the standard of care or when it is absent.
“This clinical trial has been designed to test the safety and preliminary efficacy in patients representing three indications — two in HCC and one in liver metastases,” Elsa Borghi, MD, chief medical officer of Nanobiotix, said in the release. “Structure and number of patients per group have been chosen based on statistical hypothesis in comparison with literature for an efficient early de-risking. This approach could allow rapid efficacy results to be gathered, opening a faster pathway to market.”
In the phase 1 trial, three different types of tumors will be treated with increasing volumes of NBTXR3. The goal of this study is to determine the recommended dose, which will then be evaluated further in the phase 2 trial, according to the release.
In the phase 2 trial, three different patient groups — patients with primary cancer with and without intrahepatic thrombosis of the portal vein trunk and patients with secondary liver cancer — will be investigated simultaneously.
NBTXR3 is activated by radiotherapy and works by the deposit of increased energy doses within the tumor. “NBTXR3 may significantly increase the intratumor energy dose with higher destruction and improve the patient outcome in terms of higher tumor shrinkage, local control and overall survival,” according to the Nanobiotix website.
Disclosures: Borghi reports being employed by Nanobiotix.