An Early Phase 1 interventional study of Azeliragon and Temozolomide in Glioblastoma, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 12 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ and bone marrow function as defined below:
Exclusion Criteria:
Radiation therapy (RT) will consist of fractionated RT to 60 Gy in 30 daily fractions administered per standard of care RTOG approach. Concurrent TMZ during RT will be self-administered by mouth (PO) as per standard of care. 1 month after completion of RT, patient will proceed with planned surgery of either resection or LITT. Patients will then receive adjuvant TMZ and azeliragon for up to 6 months. Patient should start with the loading dose 30 mg BID for 6 days before the start of adjuvant TMZ. After 6 days, azeliragon 20 mg once daily should be continued in combination with TMZ.
Drug: Azeliragon · Drug: Temozolomide · Radiation: Radiation therapy · Procedure: Surgery or LITT
RT will consist of fractionated RT to 60 Gy in 30 daily fractions administered per standard of care RTOG approach. Concurrent TMZ during RT will be self-administered by mouth (PO) as per standard of care. Patients will receive azeliragon as well. Azeliragon is self-administered PO. Azeliragon dosing will consist of 6 days of a loading dose of 30 mg twice per day starting on day -6, followed by 20 mg daily starting on the Day 1. Concurrent RT and TMZ start on Day 1. Azeliragon should continue until the day before planned surgical procedure. 1 month after completion of RT, patient will proceed with planned surgery of either resection or LITT. Patients will then receive adjuvant TMZ and azeliragon for up to 6 months. Patient should start with the loading dose 30 mg BID for 6 days before the start of adjuvant TMZ. After 6 days, azeliragon 20 mg once daily should be continued in combination with TMZ.
Drug: Azeliragon · Drug: Temozolomide · Radiation: Radiation therapy · Procedure: Surgery or LITT
Provided by Cantex Pharmaceuticals
Standard of care.
Also known as: TMZ
Standard of care.
Standard of care surgical resection or laser interstitial thermal therapy (LITT).
Percentage of immune-suppressive myeloid cells in the tumor tissue
Time frame: At time of surgery or LITT (estimated to be day 60)
Percentage of immune-suppressive T cells in the tumor tissue
Time frame: At time of surgery or LITT (estimated to be day 60)
Number of participants with adverse events
Time frame: From day 1 (Arm 1) or Day -6 (Arm 2) through 30 days after last dose of azeliragon (estimated to be 10 months)
Number of participants with intolerable toxicities
The protocol lists the specific toxicities that are considered intolerable.
Time frame: From first dose of azeliragon until 30 days after the last dose (estimated to be 6-9 months)
Progression-free survival (PFS)
Time frame: Up to 12 months after completion of study treatment (estimated to be 21 months)
Overall survival (OS)
Time frame: Up to 12 months after completion of study treatment (estimated to be 21 months)
Feasibility of the regimen as measured by the number of participants who proceed with post-chemoradiotherapy surgery or LITT
Feasibility is defined as at least 50% of patients in each arm who are able to proceed with post-chemoradiotherapy surgery or LITT.
Time frame: Through surgery or LITT (estimated to be 60 days)
Plan to share: No
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Washington University School of Medicine