Azeliragon with Chemoradiotherapy for Glioblastoma
This study is looking at a new approach for people with newly diagnosed glioblastoma (a type of brain cancer). It combines standard treatments like radiation therapy and temozolomide (a chemotherapy drug) with a drug called azeliragon. Researchers want to see if adding azeliragon can help reduce certain immune cells (immune-suppressive myeloid cells and T cells) in the tumor that might prevent other treatments from working well. You could be eligible if you have a specific type of glioblastoma (IDH-wildtype GBM, WHO grade 4) and still have some tumor remaining after initial surgery or biopsy. The study aims to enroll 12 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 12 participants. The phase of the study is not specified.
- What's involved
- Participants will receive azeliragon, temozolomide, and radiation therapy. They will also undergo surgery or LITT (laser interstitial thermal therapy) to sample the tumor around day 60.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints, which measure immune cells in the tumor, are assessed at the time of surgery or LITT, estimated to be around day 60.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06831526
Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentWashington University School of MedicineInvestigator-initiated
~12 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:AzeliragonTemozolomideRadiation therapySurgery or LITT
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of immune-suppressive myeloid cells in the tumor tissue
Measured over At time of surgery or LITT (estimated to be day 60)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesMissouri1
Study leadership
- Jiayi Huang, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically proven diagnosis of IDH-wildtype GBM (WHO grade 4) according to the 2021 WHO classification (including subtypes such as gliosarcoma).
Radiographic evidence of residual tumor after initial surgery or biopsy.
Patient is amenable for future surgery (either surgical resection or laser interstitial thermal therapy (LITT)) to sample the residual tumor after completion of chemoradiotherapy.
At least 18 years of age.
Eligible for and planning to receive standard fractionated RT of 60 Gy with concurrent TMZ.
Recovered from the effects of surgery, postoperative infection, and other complications sufficiently for initiation of chemoradiotherapy, in the opinion of the treating physician.
Karnofsky performance status ≥ 60.
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
If there is history of human immunodeficiency virus (HIV) infection, patients must be on effective antiretroviral therapy, and HIV viral load must be undetectable within 6 months of study enrollment.
If there is history of chronic hepatitis B virus (HBV) infection, patients must have either been treated or are on suppressive therapy (as indicated), and HBV viral load must be undetectable.
If there is history of hepatitis C virus (HCV) infection, patients must have been treated, and HCV viral load must be undetectable.
Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) and sexually active heterosexual males must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the trial and for 6 months after the last administration of azeliragon. Should a female trial participant or female partner of a male trial participants become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Able to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion
Prior cranial RT or RT to the head and neck where potential field overlap may exist.
Leptomeningeal or metastatic involvement.
Known IDH mutation. IDH status could be determined by either immunohistochemistry or sequencing as evaluated per routine clinical care.
Patients receiving CYP 2C8 inhibitors within 2 weeks or 5 half-lives prior to study entry.
Patients with a gastrointestinal condition that could interfere with swallowing or absorption.
Patients with concurrent participation in another interventional clinical trial or use of another investigational agent within 30 days prior to study entry. Patients who are participating in non-interventional clinical trials (e.g., QOL, imaging, observational, follow-up studies, etc.) are eligible, regardless of the timing of participation.
Medical contraindication to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis).
Pregnant or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of the first dose of RT (Arm 1) or azeliragon (Arm 2).
Patients with psychiatric illness/social situations, including alcohol or drug abuse that in the investigator's opinion will prevent administration or completion of protocol therapy.
Non-English speaking, as the cognitive assessments will only be available in English
What this trial measures
- Percentage of immune-suppressive myeloid cells in the tumor tissueAt time of surgery or LITT (estimated to be day 60)
- Percentage of immune-suppressive T cells in the tumor tissueAt time of surgery or LITT (estimated to be day 60)