“We believe that NBTXR3 could have a positive impact for patients with cancer in any case where radiotherapy is a part of the standard of care. Expansion into esophageal cancer represents not only another step toward achieving our goals, it also highlights the ongoing progress of our clinical collaboration agreement with The University of Texas MD Anderson Cancer Center.” – Laurent Levy, CEO of Nanobiotix
Paris, France ; Cambridge, Massachusetts (USA) ; January 28, 2021 – NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ‘‘Company’’), a clinical-stage biotechnology company focused on developing first-in-class product candidates that use proprietary nanotechnology to transform the treatment of cancer, today announced that the first patient has been injected in a phase I study evaluating tumor-agnostic NBTXR3 activated by radiation therapy with concurrent chemotherapy for patients with esophageal cancer. The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson) as part of an ongoing clinical collaboration.
Background and Opportunity
According to the World Health Organization, esophageal cancer is currently the sixth most common cause of cancer death in the world and is estimated to have caused over 508,585 deaths in 2018. The American Cancer Society estimates that in 2020 in the United States, there were approximately 18,440 new esophageal cancer cases diagnosed, and approximately 16,170 deaths due to esophageal cancer. Approximately 20% of patients survive esophageal cancer at least five years after diagnosis.
Phase I Study of NBTXR3 Activated by Radiotherapy with Concurrent Chemotherapy for Patients with Esophageal Cancer (MD Anderson Study 2020-0122)
This study is an open-label, single-arm, prospective phase I study consisting of two parts: (i) dose-escalation to determine the RP2D of NBTXR3 activated by radiotherapy with concurrent chemotherapy, and (ii) expansion at RP2D with toxicity monitoring.
The patient population will include adults (age ≥ 18 years) with stage II-III adenocarcinoma of the esophagus that are treatment-naïve and radiographically non-metastatic at screening. The number of participants enrolled will be determined based on the maximum number required to establish the RP2D of NBTXR3 activated by radiation therapy. Up to 24 subjects will be enrolled, including a maximum of 12 subjects for the dose-escalation part. Twelve additional subjects will be enrolled for the RP2D expansion part. Recruitment is ongoing and the planned enrollment period is 24 months.
Updates on this trial will be provided as they are made available by MD Anderson.