Clinical Data NBTXR3

2022 – NBTXR3, a first-in-class radioenhancer for pancreatic ductal adenocarcinoma

Clinical Data NBTXR3, NO-RIGHTS, Pancreas, Publications

Pancreatic ductal adenocarcinoma (PDAC) remains one of the leading causes of cancer-related deaths in the world. For patients with PDAC who are not eligible for surgery, radiation therapy improves local disease control, yet safely delivering therapeutic doses of radiation remains challenging due to off-target toxicities in surrounding normal tissues. NBTXR3, a novel radioenhancer composed of functionalized hafnium oxide crystalline nanoparticles […]

2022 – Nanoparticle therapy for head and neck cancers

Clinical Data NBTXR3, Head & Neck, NO-RIGHTS, Publications

Nanoparticles are spherical nanoscale objects that have application in cancer therapies. Nanoparticles have diverse and often composite structure composition to ensure their function, increase their bioavailability in tumor tissues, and decrease off-target effects, sometimes by means of activating internal or external stimuli. Hafnium oxide nanoparticles are being tested in phase I to III trials for radiotherapy enhancement. […]

2021 – Eur J Surg Oncol – STS Retrospective Study

Clinical Data NBTXR3, NO-RIGHTS, Publications, STS

Locally advanced soft tissue sarcoma (STS) management may include neoadjuvant or adjuvant treatment by radiotherapy (RT), chemotherapy (CT) or chemoradiotherapy (CRT) followed by wide surgical excision. While pathological complete response (pCR) to preoperative treatment is prognostic for survival in osteosarcomas, its significance for STS is unclear. We aimed to evaluate the prognostic significance of pCR to pre-operative treatment on 3-year disease-free survival (3y-DFS) in STS patients. […]

2021 – Eur J Cancer – NBTXR3 Phase I in HNSCC

Clinical Data NBTXR3, Head & Neck, NO-RIGHTS, Publications

This phase I study assessed the safety of first-in-class radioenhancer nanoparticles, NBTXR3, in elderly or frail patients with locally advanced head and neck squamous cell carcinoma (HNSCC), ineligible for chemoradiation. This is an observational, retrospective, international, study of adult patients with primary non-metastatic STS of the extremities and trunk wall, any grade, diagnosed between 2008 and 2012, treated with at least neoadjuvant treatment and surgical resection and observed for a minimum of 3 years after diagnosis. […]

2019 – The Lancet Oncology – Act.In.Sarc

Clinical Data NBTXR3, NO-RIGHTS, Publications, STS

Pathological complete response to preoperative treatment in adults with soft-tissue sarcoma can be achieved in only a few patients receiving radiotherapy. This phase 2–3 trial evaluated the safety and efficacy of the hafnium oxide (HfO2) nanoparticle NBTXR3 activated by radiotherapy versus radiotherapy alone as a pre-operative treatment in patients with locally advanced soft-tissue sarcoma. Act.In.Sarc is a phase 2–3 randomised, multicentre, international trial. Adults (aged ≥18 years) with locally advanced soft-tissue sarcoma of the extremity or trunk wall, of any histological grade, and requiring preoperative radiotherapy were included. […]

2016 – Phase I data NBTXR3 Soft Tissue Sarcoma – Bonvalot et al.

Clinical Data NBTXR3, NO-RIGHTS, Publications, STS

This phase I study aimed to determine the recommended dose (RD), safety profile, and feasibility of a procedure combining intratumoral injection of hafnium oxide nanoparticles (NBTXR3; a radioenhancer) and external beam radiotherapy (EBRT) for preoperative treatment of adults with locally advanced soft tissue sarcoma (STS). Patients had a preoperative indication of EBRT for STS of the extremity or trunk. Baseline tumor volume (TV) was calculated by MRI. NBTXR3 was injected percutaneously into tumors at 53.3 g/L. Dose escalation was based on four levels equivalent to 2.5%, 5%, 10%, and 20% of baseline TV. NBTXR3 was visualized in the tumor 24 hours postinjection, and EBRT was initiated (50 Gy over 5 weeks).

2014 – Metals as Nanosized Radioenhancers – Pottier et al.

Clinical Data NBTXR3, Head & Neck, NO-RIGHTS, Publications

Since the discovery of cisplatin about 40 years ago, the design of innovative metal-based anticancer drugs is a growing area of research. Transition metal coordination complexes offer potential advantages over the more common organic-based drugs, including a wide range of coordination number and geometries, accessible redox states, tunability of the thermodynamics and kinetics of ligand substitution, as well as a wide structural diversity. Metal-based substances interact with cell molecular targets, affecting biochemical functions resulting in cancer cell destruction. Radionuclides are another way to use metals as anticancer therapy.

Publications in this section cover results of clinical trials with NBTXR3. The reports are published in peer-reviewed journals.

2022 – NBTXR3, a first-in-class radioenhancer for pancreatic ductal adenocarcinoma

2022 – Nanoparticle therapy for head and neck cancers

2021 – Eur J Surg Oncol – STS Retrospective Study

2021 – Eur J Cancer – NBTXR3 Phase I in HNSCC

2019 – The Lancet Oncology – Act.In.Sarc

2016 – Phase I data NBTXR3 Soft Tissue Sarcoma – Bonvalot et al.

2014 – Metals as Nanosized Radioenhancers – Pottier et al.