Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06831526

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

Led by Washington University School of Medicine · Updated on 2025-11-12

12

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

C

Cantex Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of IDH-wildtype glioblastoma (WHO grade 4) including subtypes like gliosarcoma
  • Evidence of residual tumor after initial surgery or biopsy shown by imaging
  • Amenable to future surgery or laser interstitial thermal therapy (LITT) to sample residual tumor after chemoradiotherapy
  • At least 18 years old
  • Eligible for and planning to receive standard fractionated radiation therapy (60 Gy) with concurrent temozolomide
  • Recovered sufficiently from surgery and complications to start chemoradiotherapy as judged by treating physician
  • Karnofsky performance status of 60 or higher
  • Adequate organ and bone marrow function including neutrophil count ≥1.5 K/cumm, platelets ≥100 K/cumm, hemoglobin >9.0 g/dL, total bilirubin ≤1.5 ULN, AST and ALT ≤3 times ULN, creatinine ≤1.5 ULN or creatinine clearance ≥60 mL/min
  • If history of HIV infection, must be on effective therapy with undetectable viral load within 6 months
  • If history of chronic hepatitis B, must be treated or on suppressive therapy with undetectable viral load
  • If history of hepatitis C, must have been treated with undetectable viral load
  • Females of childbearing potential and sexually active heterosexual males must agree to use effective birth control during the study and for 6 months after last azeliragon dose
  • Able to understand and willing to sign informed consent or have a legally authorized representative do so
Not Eligible

You will not qualify if you...

  • Prior cranial radiation therapy or radiation to head and neck with potential overlap of treatment fields
  • Presence of leptomeningeal or metastatic disease
  • Known IDH mutation in tumor
  • Use of CYP 2C8 inhibitors within 2 weeks or 5 half-lives before study entry
  • Gastrointestinal conditions that interfere with swallowing or absorption
  • Participation in another interventional clinical trial or use of investigational agents within 30 days before study entry
  • Medical contraindications to MRI such as incompatible implants, pacemaker, inability to lie still, or severe kidney disease
  • Pregnant or breastfeeding; females of childbearing potential must have negative pregnancy test within 14 days before first dose
  • Psychiatric illness or social situations including alcohol or drug abuse that may prevent completion of therapy
  • Non-English speaking due to cognitive assessments only being available in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

J

Jiayi Huang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here