XRD-0394 with Radiation for High-Grade Gliomas
This study is testing a new drug called XRD-0394 along with radiation therapy for people with high-grade glioma (a type of brain tumor). XRD-0394 is a pill that works by blocking two specific proteins (ATM and DNA-PK) that help cancer cells repair their DNA. The study aims to find the safest dose of XRD-0394 when given with radiation, and sometimes with another drug called temozolomide, for both newly diagnosed and recurring high-grade gliomas. You may be able to join if you are 18 years or older and have a high-grade glioma confirmed by imaging or biopsy. The main goal is to see how many participants experience side effects that limit the dose of the drug.
- Study design
- This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It's a dose-finding study, aiming to find the right dose of the new drug, and plans to enroll 39 participants.
- What's involved
- You would receive XRD-0394 orally, along with radiation therapy and possibly surgical removal of tumor tissue. The study involves a specific schedule of radiation doses, including a break between treatments.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will monitor for dose-limiting side effects at specific times, ranging from Day 8 to Day 108, depending on your treatment group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06829173
Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas
Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatmentNYU Langone HealthInvestigator-initiated
~39 participants
Updated 2026-01-02 on ClinicalTrials.gov
What's tested:XRD-0394Radiation TherapySurgical Resection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants who Experience Dose-Limiting Toxicities (DLTs)
Measured over End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108)
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Jonathan Yang, MD, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
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
Willing and able to provide written informed consent.
≥18 years of age.
For Cohorts A and B, radiographic diagnosis of high-grade glioma that is then confirmed with biopsy. Patients with established histologic diagnosis of high-grade glioma is able to enroll on the study without repeating biopsy.
For Cohort C, histologic diagnosis of high-grade glioma is required to enroll on the study.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
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.
Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy. Female subjects of childbearing potential who are undergoing RT or who are partners to male subjects in the study should avoid sexual activity or use a highly effective method of birth control during sexual intercourse. Acceptable, highly effective methods of birth control include intrauterine device (IUD)/intrauterine hormone releasing system (IUS), bilateral tube occlusion, vasectomized partner, combined (estrogen and progesterone containing) or progesterone-only hormonal contraceptives (oral, intravaginal, transdermal, injectable).
Subjects receiving anti-glioma therapy are eligible if treatment can be held 14 days before the first XRD-0394 dose and resume a minimum of 5 days after completion of XRD-0394 (Cohort C only).
Patient with recurrent tumor amendable to reirradiation and is at least 3 months from end of prior brain radiation therapy (Cohort C only)
Subjects taking glucocorticoids before and during protocol treatment period will be included per the discretion of the investigator. Intake should be minimized before and during treatment.
Exclusion
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)
Subjects with bone marrow impairment as evidenced by hemoglobin \<8.0 g/dL, neutrophil count \<1.5 × 109/L, or platelets \<100 × 109/L.
History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
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.
Participation in another investigational study of an unapproved drug or device or 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.
Subjects who are pregnant or breast-feeding.
Subjects with a QTc interval \>450 msec (calculated using Fridericia's QT correction formula) at screening.
Contraindication to temozolomide (Cohort A only)
Severe headache, rapidly progressive neurologic decline, objective neurologic manifestations of uncal herniation, depressed level of consciousness
Subjects receiving treatment with any drug that is a strong inhibitor or inducer of CYP3A4 enzyme activity or an inhibitor of BCRP within a minimum of 5 half- lives or 14 days prior to screening or during study participation.
What this trial measures
- Number of Participants who Experience Dose-Limiting Toxicities (DLTs)End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108)
Assessed among patients who receive at least one dose of the study drug and are evaluated for dose-limiting toxicities (DLTs).