Clinical Data NBTXR3

Abstracts in this section cover results of clinical trials with NBTXR3.

2021 – Radiation enhancing NBTXR3 for the treatment of cisplatin-ineligible locally advanced HNSCC patients

The non-surgical standard of care (SOC) for the treatment of locally advanced head and neck squamous cell carcinoma(LA HNSCC) is concurrent chemoradiation with high dose cisplatin or cetuximab in case of contra-indication to cisplatin. However elderly patients, and those with poor performance status, comorbidities, and/or intolerance, may not benefit from these SOC treatments and represent a high unmet need. […]

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2021 – Results from the phase I dose-escalation study of the radiation enhancer NBTXR3 for the treatment of HCC and liver metastases

Treatment of unresectable liver cancer or liver metastases (mets) by stereotactic body radiotherapy is well tolerated but limited by the need to preserve liver function. Increasing energy deposition in the tumor while at the same time maintaining the dose in healthy tissue remains a major challenge in radiation oncology that could be achieved by NBTXR3 (hafnium oxide nanoparticles) when activated by radiotherapy (RT). […]

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2021 – A new radio-enhancer, PEP503 (NBTXR3), in combination with concurrent chemoradiation in locally advanced or unresectable rectal cancer: The dose-finding part of a phase I/II trial

PEP503 (as known as NBTXR3) is a novel radio-enhancer composed of functionalized hafnium oxide nanoparticles for a higher energy deposit by radiotherapy comparing to radiotherapy alone without it. A prior phase 3 study for soft tissue sarcoma has demonstrated the clinical benefit. […]

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2020 – NANORAY-103: Phase I/II trial of NBTXR3 activated by SBRT in patients with HCC and liver metastases

The use of stereotactic body radiotherapy (SBRT) for the local control of unresectable hepatocellular carcinoma (HCC) or liver metastases (mets) is well tolerated but limited by the need to preserve liver function. Increasing energy deposit within the tumor without increasing toxicity in healthy tissues remains a major challenge in radiation oncology. […]

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2020 – RT-activated hafnium oxide nanoparticles in cisplatin-ineligible locally advanced HNSCC patients

Elderly and frail patients (pts) with head and neck squamous cell carcinoma (HSNCC) remain a challenging population to manage due to the lack of evidence-based recommendations. Despite representing approximately 20% of the HNSCC population no consensus exists on the optimal treatment for these pts with locally advanced (LA) disease […]

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2020 – NBTXR3 Radiation Enhancing Hafnium Oxide Nanoparticles Activated By Radiotherapy In Combination With Anti-PD-1 Therapy: A Phase I Study

Immune checkpoint inhibitors (ICIs) are being increasingly used to improve patient outcomes across different cancer types. However, the response rate to ICIs remains low (∼15%), indicating the need for novel strategies to improve treatment outcome. Emerging evidence suggests that radiation therapy (RT) could potentially enhance the antitumor response and provide synergy with ICIs. […]

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2020 – NBTXR3 radiation enhancing hafnium oxide nanoparticles: RP2D for the treatment of HCC and liver metastases

NBTXR3, functionalized hafnium oxide nanoparticles, administered by intratumoral injection (ITI) and activated by radiotherapy (RT), such as stereotactic body RT (SBRT), increases energy deposit inside tumor cells and subsequently tumor cell death compared to RT alone, while sparing healthy tissues. This innovative approach, which does not engage liver and renal functions, might benefit patients (pts) with unresectable liver cancers. […]

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2020 – Phase I study of NBTXR3 activated by radiotherapy in patients with advanced cancers treated with an anti-PD-1 therapy

Despite the past decade of transformative advances in immuno-oncology, the response rate to checkpoint inhibitors (ICIs) remains low (~15%). There is significant interest in developing strategies to overcome resistance to these treatments, thus increasing response rate. Emerging evidence suggests that radiation therapy (RT) could potentially augment the antitumor response to ICIs through synergic effect. […]

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