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Also known as PEP503
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 product developed by Nanobiotix S.A. for use with radiotherapy. It is being studied in adult soft tissue sarcoma and in combination with radiotherapy, including settings where radiotherapy is paired with anti-PD-1 immunotherapy. It is not approved and remains in clinical development.
NBTXR3 is being studied in adult soft tissue sarcoma of the extremity and trunk wall, where it is combined with radiation therapy. The Phase 2 trial NCT02379845 randomized 180 patients with adult soft tissue sarcoma across two arms in multiple countries. NBTXR3 is investigational and has not been approved for this indication.
NBTXR3 is developed by Nanobiotix S.A., which trades under the ticker NBTX. Nanobiotix is the sponsor of the clinical program evaluating NBTXR3 in adult soft tissue sarcoma and in combination with radiotherapy and anti-PD-1 therapy.
NBTXR3 is in Phase 2 development. The completed Phase 2 trial NCT02379845 evaluated NBTXR3 with radiation therapy in 180 randomized patients with adult soft tissue sarcoma. NBTXR3 is investigational and has not been approved by the FDA.
NBTXR3 has been studied in three registered trials. NCT02379845 was a completed Phase 2 randomized trial in adult soft tissue sarcoma with 180 patients. NCT01433068 was a completed Phase 1 trial in 22 patients in France. NCT03589339 is an active Phase 1 trial combining NBTXR3 with radiotherapy and anti-PD-1 therapy in advanced cancers.
NBTXR3 is not approved by the FDA. It is an investigational product still in clinical development, currently in Phase 2. The completed Phase 2 trial NCT02379845 studied NBTXR3 with radiation therapy in randomized patients with adult soft tissue sarcoma of the extremity and trunk wall.