NBTXR3 + Radiotherapy for Cancer
Trial Summary
What is the purpose of this trial?
The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received certain cancer treatments or vaccines recently, and you should discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment NBTXR3 + Radiotherapy for Cancer?
Research shows that NBTXR3, when combined with radiotherapy, has shown clinical activity in various cancers like soft tissue sarcoma and head and neck cancer. Additionally, in animal studies, NBTXR3 combined with immunotherapy improved survival and created long-term immune memory against tumors.12345
Is NBTXR3 + Radiotherapy safe for humans?
NBTXR3, a type of hafnium oxide nanoparticle, has been used in clinical studies for various cancers, including pancreatic cancer, and has shown clinical activity. However, delivering radiation safely remains challenging due to potential toxicities in surrounding normal tissues. Pembrolizumab and nivolumab, which are sometimes used in combination with NBTXR3, have been associated with cardiac-related toxicities, so monitoring for heart-related side effects is important.12567
What makes the NBTXR3 + Radiotherapy treatment unique for cancer?
The NBTXR3 + Radiotherapy treatment is unique because it combines hafnium oxide nanoparticles (NBTXR3) with radiotherapy to enhance the effectiveness of the radiation, while also using immune checkpoint inhibitors like nivolumab and pembrolizumab to boost the body's immune response against cancer cells. This combination aims to improve treatment outcomes by both directly targeting the tumor and enhancing the immune system's ability to fight cancer.56789
Research Team
Pavel Tyan, MD
Principal Investigator
Nanobiotix
Eligibility Criteria
This trial is for adults with advanced cancers like lung, kidney, bladder, skin cancer and more who have a life expectancy over 12 weeks. They must be able to receive radiotherapy and not have had certain treatments recently or suffer from conditions like severe heart failure or active infections.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intratumoral injection of NBTXR3 activated by radiotherapy followed by anti-PD-1 therapy
Follow-up
Participants are monitored for long-term safety and efficacy
Treatment Details
Interventions
- NBTXR3
- Nivolumab
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nanobiotix
Lead Sponsor