Lumos Pharma
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.
The study will enroll subjects 5 to 21 years of age with relapsed or refractory primary brain or spinal malignancy of any histology, who have exhausted available curative treatment options. A standard 3+3 dose-escalation design will be used to determine the pediatric maximum tolerated dose (MTD) for NLG802 indoximod prodrug in combination with temozolomide (Treatment Regimen). The MTD of NLG802 for the Treatment Regimen will be the highest dose level where no more than 1 of 6 subjects have (a) Regimen-Limiting Toxicity(/ies) (RLT\[s\]) in Cycle 1, which will be 28 days duration plus any toxici…
Inclusion Criteria: * 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. * Collection of baseline blood samples for required biomarker correlate trials. * Performance score: Lansky or Karnofsky performance status score must be ≥ 70. * Life expectancy must be ≥ 3 months. * Hemoglobin ≥ 10…
NLG802 will be taken by mouth twice daily, throughout each treatment cycle.
Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.
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