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NBTXR3 · 3 trials · 12 indications
To compare antitumor activity in terms of Pathological complete response rate (pCRR) of intratumor injection of NBTXR3 activated by external beam radiation therapy (EBRT), versus EBRT alone
Determination of DLTs, the MTD (if possible), and RP2Ds for each cohort
Incidence of Grade 3 and higher treatment-related AEs
\- To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall
\- To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | NBTXR3 + Radiotherapy |
| Arm B | ACTIVE_COMPARATOR | Radiotherapy alone |
| NBTXR3 activated by SABR followed by anti-PD-1 monotherapy | EXPERIMENTAL | Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab |
| NBTXR3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NBTXR3 | DEVICE | One intratumor implantation by injection |
| Radiation therapy | DEVICE | 5 weeks/50 Gy (5 x 2 Gy by week) |
| SABR | RADIATION | Radiotherapy given as a definite number of fractions at the dose defined for each radiation field |
| Nivolumab | DRUG | Anti-PD-1 monotherapy |
| Pembrolizumab | DRUG | Anti-PD-1 monotherapy |
Inclusion Criteria: * Age: 18 years and older * Locally Advanced Soft Tissue Sarcoma of the Extremity and Trunk Wall * All grades * Candidate to radiotherapy + surgery (ESMO guideline 2014) i.e. tumor must not have involvement of bone and / or vessel and or nerve : * Primary tumor or, * Relaps...
NBTXR3 is an investigational oncology therapy being studied for adult soft tissue sarcoma of the extremity and trunk wall, where it is administered with radiation therapy. It is also being evaluated in combination with anti-PD-1 immunotherapy for advanced cancers, including metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, and other solid tumors.
NBTXR3 is a crystalline nanoparticle designed to be activated by radiation therapy. When injected into the tumor and exposed to radiation, it is intended to increase the local radiation dose within cancer cells, potentially enhancing tumor cell destruction while sparing surrounding healthy tissue. Its mechanism does not involve a traditional molecular target.
NBTXR3 is being developed by Nanobiotix S.A., a biopharmaceutical company. The company's stock is listed under the ticker symbol NBTX.
NBTXR3 has completed a Phase 2 clinical trial in adult soft tissue sarcoma of the extremity and trunk wall. It has also been studied in Phase 1 trials, including one that is active but not recruiting, evaluating the drug in combination with anti-PD-1 therapy for advanced cancers. It remains an investigational agent in clinical development.
NBTXR3 has been studied in several clinical trials. NCT01433068 was a completed Phase 1 trial in adult soft tissue sarcoma. NCT02379845 was a completed Phase 2 randomized trial in soft tissue sarcoma of the extremity and trunk wall. NCT03589339 is an active Phase 1 trial combining NBTXR3 with anti-PD-1 therapy for advanced cancers.
Yes, NBTXR3 is also referred to as NBTXR3 crystalline nanoparticles in clinical trial titles. The drug is a hafnium oxide nanoparticle formulation designed to be activated by radiation therapy.