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OncoMatch/Clinical Trials/NCT06829173

Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas

Is NCT06829173 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies XRD-0394 for high-grade glioma.

Early Phase 1RecruitingNYU Langone HealthNCT06829173Data as of Jun 2026

Treatment: XRD-0394This 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.

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Extracted eligibility criteria

Treatments studied

Other

XRD-0394

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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Frequently asked questions

Is NCT06829173 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy, anti-glioma systemic therapy, ATM inhibitor disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Glioblastoma trials