Actively Recruiting
Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas
Led by NYU Langone Health · Updated on 2026-01-02
39
Participants Needed
1
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- 18 years of age or older.
- For Cohorts A and B, radiographic diagnosis of high-grade glioma confirmed with biopsy or prior established histologic diagnosis.
- For Cohort C, histologic diagnosis of high-grade glioma is required.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate liver function: liver transaminase levels ≤2.5 times the upper limit of normal (ULN); total bilirubin ≤1.5 times ULN (up to 5 times ULN allowed in Gilbert's Disease).
- Adequate kidney function: creatinine clearance ≥60 mL/min.
- Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use highly effective birth control.
- Subjects receiving anti-glioma therapy must be able to hold treatment 14 days before first XRD-0394 dose and resume at least 5 days after completion (Cohort C only).
- Patients with recurrent tumor amenable to reirradiation and at least 3 months since prior brain radiation therapy (Cohort C only).
- Subjects taking glucocorticoids may be included at investigator discretion with minimized intake before and during treatment.
You will not qualify if you...
- Prior radiotherapy to the same region or prior anti-glioma systemic therapy in newly diagnosed HGG patients (Cohorts A and B).
- Bone marrow impairment: hemoglobin <8.0 g/dL, neutrophil count <1.5 × 10^9/L, or platelets <100 × 10^9/L.
- History of swallowing difficulties, malabsorption, chronic gastrointestinal disease, or use of PEG tubes.
- Significant cardiac conduction abnormalities including long corrected QT interval (>450 msec) or pacemaker, or impaired cardiovascular function (NYHA class >2).
- Participation in another investigational study with unapproved drugs or ATM, DNA-PK, or ATR inhibitors within 28 days before XRD-0394.
- Pregnant or breastfeeding women.
- QTc interval >450 msec at screening.
- Contraindication to temozolomide (Cohort A only).
- Severe headache, rapid neurological decline, signs of uncal herniation, or depressed consciousness.
- Treatment with strong CYP3A4 enzyme inhibitors or inducers or BCRP inhibitors within 5 half-lives or 14 days before screening or during study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
J
Jonathan Yang, MD, PhD
CONTACT
C
Cancer Trials NYU Langone
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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