A Phase 0/I Study to Assess the Safety and Tolerability of XRD-0394 in Combination With Radiation Therapy in Patients With High Grade Gliomas
NYU Langone Health
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugXRD-0394
Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK.
- RadiationRadiation Therapy
For Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT. For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions.
- ProcedureSurgical Resection
Resection of tumor tissue.
Location
- NYU Langone HealthNew York, New York