According to Targeted Oncology, the first patient was dosed in a Phase 1 clinical trial evaluating NBTXR3, an investigational tumor-agnostic radio enhancer, for patients with esophageal cancer. The trial will explore the therapy’s safety, efficacy, and tolerability both alone and in conjunction with other treatments.
Nanobiotix describes NBTXR3 as:
our leading, fully patented, first-in-class product candidate, designed to destroy tumors through physical cell death when activated by radiotherapy. It is developed to be used alone or in combination with anti-PD-1 immunotherapy, across different standards of care.
In 2019, NBTXR3, under the brand name Hensify, received the French Prix Galien Award for Innovation. It is currently available in Europe for the treatment of soft tissue sarcoma. Outside of that, Nanobiotix has been exploring NBTXR3 as a potential treatment option for many other forms of cancer. For example, it has shown promise when combined with radiotherapy and chemotherapy for patients with rectal cancer. In one study, 70% of patients saw a response.
This Phase 1 clinical trial will explore NBTXR3 as its own agent, as well as with immune checkpoint inhibitors and chemotherapy. Altogether, 24 patients will enroll. At this point in time, the trial is still recruiting patients. Patients must be ages 18+ with previously untreated stage 2-3 esophageal cancer. Trial endpoints include dose-limiting toxicities, the highest possible dose, response rate, progression-free survival and overall survival, and whether the treatment can be directly injected into the esophagus.
In pre-clinical studies, researchers determined that NBTXR3 had an abscopal effect. Basically, this means that not only did the treated tumors shrink, but untreated tumors outside the scope of local therapy also shrank. Additionally, NBTXR3 conferred anti-tumor response, allowing for some level of protection, especially when used with radiation.
As its name suggests, esophageal cancer occurs in the esophagus, the long tube which runs from your throat to your stomach. Normally, the esophagus plays a role in swallowing, moving food from the back of the throat to the stomach. Typically, esophageal cancer begins in the inner esophageal cells but later spreads outwards. There are multiple forms of esophageal cancer, including small cell carcinoma, choriocarcinoma, squamous cell carcinoma (the most common form globally), and adenocarcinoma (the most common form in the US). Risk factors for esophageal cancer include smoking or alcohol use, acid reflux, obesity, and being male. Symptoms usually appear in later stages and include:
- Painful or difficult swallowing
- Progressively worsening heartburn and indigestion
- Esophageal obstruction
- Unintended weight loss
- Chest and bone pain
- Chronic cough
- Nausea and vomiting (may include bloody vomit)
- Dark and/or bloody stool
- Appetite loss
Learn more about esophageal cancer.