A Phase 0/2 Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma
The aim of this clinical trial is to evaluate the feasibility of undertaking a Phase 0 surgical study in patients with diagnosis of a IDH1 mutated Low Grade Glioma (LGG) who have not received prior radiation or chemotherapy and are planned to undergo surgical resection.
• Histologically confirmed LGG or new diagnosis of LGG based on MRI
• Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon
• Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour.
• Patients who do not require immediate definitive resection of the brain tumour in the opinion of the treating neurosurgeon
• Measurable and/or evaluable disease as per LGG-RANO criteria
• Age ≥ 18 years of age.
• ECOG performance score 0-1
• Life expectancy of at least 24 months, in the opinion of the investigator
• Adequate haematological, renal and hepatic function
⁃ Reproductive and contraception criteria as prescribed