This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in combination with temozolomide chemotherapy in children with primary brain tumors.
Age must be ≥ 5 years and < 22 years.
Subjects must have relapsed or treatment-refractory primary brain or spinal malignancy of any histology.
Subjects are allowed to have surgical debulking and/or radiation/proton therapy prior to enrollment in this trial.
Tumor tissue is required for central review of tissue diagnosis and biomarker correlate studies.
Unable to swallow capsules.
Active therapy for radiation necrosis.
Baseline QTcB of > 470 msec at screening, and subjects with known congenital long QT syndrome.
Clinically significant cardiovascular disease.