ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors

Exclusion Criteria

• •1. Urgent need for surgical intervention
• •2. Alanine aminotransferase or aspartate aminotransferase \> 10 times the upper reference limit at the screening visit
• •3. Estimated glomerular filtration rate \< 60 mL/min (calculated using the using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation) at the screening visit
• •4. Any haematological National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 Grade ≥ 3 (with the exception of alopecia) at the screening visit
• •5. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhoea, short bowel syndrome, and/or intestinal obstruction
• •6. Hypertension that cannot be reduced to normal range with antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
• •7. Concurrent active cancer that requires non-surgical treatment (e.g., chemotherapy, radiotherapy, adjuvant therapy)
• •8. History of severe cardiovascular disease: myocardial ischemia or myocardial infarction of Grade 2 or above, poorly controlled arrhythmia (including QTc interval ≥450 ms for men, ≥470 ms for women); according to New York Heart Association standards, Grade 3 or 4 cardiac insufficiency, or colour doppler ultrasound examination of the left ventricular ejection fraction \< 50% as assessed at the screening visit
• •9. In the Investigators opinion, the subject's involvement may affect the progress of the clinical study and/or the determination of the research results, and/or considers them unsuitable for inclusion
• •10. Previously suffered severe cardiovascular disease: myocardial ischemia or myocardial infarction of Grade 2 or above, poorly controlled arrhythmia (including QTc interval ≥450 ms for men, ≥470 ms for women); according to New York Heart Association standards, Grade 3 or 4 cardiac insufficiency, or color doppler ultrasound examination of the left ventricular ejection fraction \< 50%.
• •11. Investigator judges that may affect the progress of the clinical study and/or the determination of the research results, and/or considers them unsuitable for inclusion.