RecruitingEarly Phase 1NCT06831526

Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma

A Window-of-opportunity Early Phase I Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma

Sponsor

Washington University School of Medicine

Enrollment

12 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

Glioblastoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a drug called azeliragon to standard treatment (radiation plus temozolomide chemotherapy) improves outcomes in patients with newly diagnosed glioblastoma — the most aggressive form of brain cancer. After initial treatment, participants will undergo surgery or a laser procedure to remove remaining tumor and assess how well the drug worked. **You may be eligible if...** - You have been newly diagnosed with IDH-wildtype glioblastoma (WHO grade 4 brain cancer) confirmed by pathology - There is visible tumor remaining after your initial surgery - You are at least 18 years old - You are well enough to receive standard radiation and chemotherapy (Karnofsky score at least 60%) - You are able to undergo a follow-up surgical procedure after completing chemoradiation **You may NOT be eligible if...** - You cannot tolerate standard chemoradiation - You have insufficient recovery from your initial brain surgery - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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