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.
Sequential
NLG802 (indoximod Prodrug)
DrugNLG802 will be taken by mouth twice daily, throughout each treatment cycle.
Temozolomide
DrugTemozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.
Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.
Determined by number of patients with dose limiting toxicities.
Incidence of Regimen-limiting toxicities in in pediatric participants for NLG802 in combination with temozolomide.
Determined by number of patients with regimen limiting toxicities.
Pharmacokinetics in pediatric participants for NLG802 in combination with temozolomide
Serum concentrations (Cmax/Steady State).
Overall survival for NLG802 in combination with temozolomide.
Evidence of efficacy for NLG802 in combination with temozolomide based on change to objective response rate.
Measured by subjects who achieve complete response, partial response or no response.
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This trial is not recruiting at the moment. You can still explore other options:
