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NCT06831526
Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma
EARLY_PHASE1 trial testing Azeliragon in Glioblastoma in 12 participants. Currently enrolling.
28 February 2029
Quick facts
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 6 November 2025 |
| Primary completion | 28 February 2029 |
| Estimated completion | 31 August 2030 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azeliragon — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
- Radiation therapy — full drug profile →
- Surgery or LITT
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
Sponsor
Washington University School of Medicine
Who can join
18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06831526
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Azeliragon
Trials testing the same drug.
- NCT05773664 — Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma · Phase 1 · withdrawn
- NCT05986851 — Azeliragon in MGMT Unmethylated Glioblastoma · Phase 2 · active not recruiting
- NCT03980730 — Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance · Phase 2 · terminated
Other recruiting trials for Glioblastoma
Currently open trials in the same condition.
- NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
- NCT05653635 — Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study · Phase 2 · recruiting
- NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma · Phase 1 · recruiting
- NCT07448480 — Comprehensive Analysis of Chemotherapy and Targeted Therapy Outcomes in Recurrent Malignant Gliomas · active not recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Washington University School of Medicine trials
Trials by the same sponsor.
- NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer · Phase 2 · not yet recruiting
- NCT07101666 — Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer · Phase 2 · not yet recruiting
- NCT07200089 — Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel) · Phase 1 · not yet recruiting
- NCT07313592 — Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients · not yet recruiting
- NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06831526 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
- Last refreshed: 12 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06831526.
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