OncoMatch/Clinical Trials/NCT06831526
Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma
Is NCT06831526 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Azeliragon and Temozolomide for glioblastoma.
Treatment: Azeliragon · Temozolomide — Preclinical data have demonstrated the combination of azeliragon, a RAGE inhibitor, with radiation therapy (RT) can effectively reduce immune-suppressive myeloid cells and restore T-cell activation to improve tumor control in murine glioma models. Ongoing clinical studies of azeliragon with RT alone and RT plus temozolomide (TMZ) to treat patients with newly diagnosed glioblastoma (GBM) have demonstrated safety and tolerability. The purpose of this window-of-opportunity study is to validate that the combination of azeliragon with RT and TMZ would modulate immune-suppressive myeloid and T cells in the tumor microenvironment in patients with GBM.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Histologically proven diagnosis of IDH-wildtype GBM (WHO grade 4) according to the 2021 WHO classification
Excluded: IDH1 mutation
Known IDH mutation [excluded]. IDH status could be determined by either immunohistochemistry or sequencing as evaluated per routine clinical care.
Disease stage
Required: Stage WHO GRADE 4 (WHO)
Grade: 4 (WHO)
WHO grade 4
Prior therapy
Cannot have received: cranial radiation therapy
Prior cranial RT or RT to the head and neck where potential field overlap may exist
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm; Hemoglobin > 9.0 g/dL (transfusion or other intervention acceptable)
Kidney function
Creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
Adequate organ and bone marrow function as defined below: Absolute neutrophil count (ANC) ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm; Hemoglobin > 9.0 g/dL (Note: the use of transfusion or other intervention to achieve Hgb >9.0 g/dL is acceptable); Total bilirubin ≤ 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 3 x ULN; Creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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