OncoMatch/Clinical Trials/NCT06829173
Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas
Is NCT06829173 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies XRD-0394 for high-grade glioma.
Treatment: XRD-0394 — This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Exception: Cohorts A and B, not applicable for Cohort C
Prior radiotherapy to the same region or prior anti-glioma systemic therapy in patients with newly diagnosed HGG (Cohorts A and B, not applicable for Cohort C)
Cannot have received: anti-glioma systemic therapy
Exception: Cohorts A and B, not applicable for Cohort C
Prior radiotherapy to the same region or prior anti-glioma systemic therapy in patients with newly diagnosed HGG (Cohorts A and B, not applicable for Cohort C)
Cannot have received: ATM inhibitor
treatment with another ATM, deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK), or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394
Cannot have received: DNA-PK inhibitor
treatment with another ATM, deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK), or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394
Cannot have received: ATR inhibitor
treatment with another ATM, deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK), or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394
Lab requirements
Blood counts
hemoglobin <8.0 g/dL, neutrophil count <1.5 × 10^9/L, or platelets <100 × 10^9/L [excluded]
Kidney function
Creatinine clearance ≥60 mL/min measured from a 24-hour urine collection or calculated based on the Cockcroft-Gault formula
Liver function
Liver transaminase levels ≤2.5 × the upper limit of normal (ULN); total bilirubin ≤1.5 × ULN, except in subjects with Gilbert's Disease in whom total bilirubin ≤5 × ULN is allowed
Cardiac function
Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome (>450 msec per Fridericia's formula) and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2 at screening. Subjects with a QTc interval >450 msec (calculated using Fridericia's QT correction formula) at screening [excluded].
Subjects must have adequate liver and kidney function, defined as: Liver transaminase levels ≤2.5 × the upper limit of normal (ULN); total bilirubin ≤1.5 × ULN, except in subjects with Gilbert's Disease in whom total bilirubin ≤5 × ULN is allowed; OR Creatinine clearance ≥60 mL/min measured from a 24-hour urine collection or calculated based on the Cockcroft-Gault formula. Subjects with bone marrow impairment as evidenced by hemoglobin <8.0 g/dL, neutrophil count <1.5 × 10^9/L, or platelets <100 × 10^9/L. Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome (>450 msec per Fridericia's formula) and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification >2 at screening. Subjects with a QTc interval >450 msec (calculated using Fridericia's QT correction formula) at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NYU Langone Health · New York, New York
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