ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma
Trial Parameters
Brief Summary
The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of one of the following: * Glioblastoma, IDH-wildtype * Grade 3 or 4 IDH1/2 mutant astrocytoma (2021 WHO classification) * Measurable disease as defined in Section 11.0 * Disease progression after previous treatment for glioma with radiation and chemotherapy * Minimum life expectancy of at least 3 months * Group C only: Dose Expansion, Brain Tumor Penetration Group: plan for radiosurgery and surgical resection as part of routine clinical care * ECOG Performance Status (PS) 0, 1 or 2 (Appendix I) * The following laboratory values obtained ≤15 days prior to registration: * Hemoglobin ≥9.0 g/dL * Leukocytes ≥3.0 x 109/L * Absolute neutrophil count (ANC) ≥1500/mm3 or 1.5 x 109/L * Platelet count ≥100,000/mm3 or 100 x 109/L * Total bilirubin ≤1.5 x ULN and \<3 mg/dL for patients with Gilbert's disease * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN * PT/INR/aPTT ≤1.5 x ULN OR if patient is receiving