OncoMatch/Clinical Trials/NCT05039632
Phase I/II Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1/L-1) for Patients With Advanced Solid Malignancies
Is NCT05039632 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for advanced malignant solid neoplasm.
This phase I/II trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 / PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and/or liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 / PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 / PD-L1 may help to control the disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Exception: Previous radiation to low dose target lesions allowed as per investigator or treating radiation oncologist discretion.
Prior radiation therapy received to the selected high dose target lesion(s)
Cannot have received: anti-neoplastic agent or immunotherapy
Exception: Except anti-PD-1/L1, which will not require a washout window. A reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator.
Has received any approved or investigational anti-neoplastic agent or immunotherapy within 2 weeks prior to NBTXR3 injection.
Cannot have received: allogenic stem cell transplantation or organ allograft
Prior allogenic stem cell transplantation or organ allograft.
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Leukocytes ≥ 1500/mm3
Kidney function
Creatinine ≤ 1.5 x upper limit of normal (ULN); Calc. creatinine clearance > 30mL/min
Liver function
Total bilirubin ≤ 2.0 mg/dL; AST / ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases
Laboratory Values at screening: Hemoglobin ≥ 9.0 g/dL; Absolute Neutrophil Count (ANC) ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Leukocytes ≥ 1500/mm3; Creatinine ≤ 1.5 x upper limit of normal (ULN); Calc. creatinine clearance > 30mL/min; Total bilirubin ≤ 2.0 mg/dL; AST / ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify