Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

Inclusion Criteria

• Be ≥18 years of age.
• Have histologically or cytologically confirmed recurrent Grade 2 or 3 LGG (oligodendroglioma or astrocytoma according to World Health Organization 2016 classification).
• Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing.
• Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR, with at least 1 non-enhancing tumor measuring 1×1×1 cm.
• Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate).
• Have KPS of ≥60%
• Have expected survival of ≥12 months.

Exclusion Criteria

• Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent <14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ≥5 half-lives of the investigational agent has elapsed.
• Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)
• Have received any prior treatment with an IDH inhibitor.
• Have received any prior treatment with bevacizumab (Avastin).