A Phase 0I Study Evaluating Safety of Oral XRD-0394 Combined with Radiation Therapy for Adults with Newly Diagnosed or Recurrent High Grade Gliomas

What this Trial Is About

Researchers are evaluating the safety and tolerability of XRD-0394, a drug given with radiation therapy, in people with newly diagnosed or recurrent high-grade gliomas, a type of brain tumor. This early-phase study aims to find the best dose of XRD-0394, which may be given with or without the chemotherapy drug temozolomide depending on patients tumor MGMT gene status. The study is open-label and includes different groups based on treatment timing and tumor characteristics. Participants receive XRD-0394 orally at varying doses during radiation therapy. Newly diagnosed patients may join a pre-surgical dose escalation phase with two dose levels before surgery. After surgery, patients with MGMT-methylated or unmethylated tumors enter separate cohorts receiving different doses of XRD-0394 two or three times weekly with radiation. Patients with recurrent tumors join a different cohort with similar dose levels during radiation. Radiation doses vary by cohort, and surgical tumor removal is part of treatment for some groups. During the study, participants undergo assessments including monitoring for dose-limiting toxicities at specific time points depending on their group. Tumor tissue is analyzed for drug concentration on the day of surgery. Researchers also track progression-free and overall survival for up to three years. Participants will have regular visits for safety and effectiveness evaluations throughout the study period, which begins with screening and includes treatment and follow-up phases lasting several months to years.

Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas