Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain… (NCT07732413) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer
United States30 participantsStarted 2026-10-08
Plain-language summary
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.
Who can participate
Age range
5 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 g/dL
* Platelets ≥ 100,000/μL
* ANC ≥ 1,000/μL
* ALT ≤ 3-times upper limit of normal.
* Total bilirubin ≤ 1.5-times upper limit of normal.
* Adequate renal function
* Seizure disorders must be well controlled with antiepileptic medication.
* Subjects must be able to swallow pills.
* Corticosteroid therapy: When necessary for adrenal replacement, subjects may receive hydrocortisone ≤ 1.7 mg/kg/day, maximum dose 70 mg/day (or equivalent).
* At the time of starting protocol therapy, subjects must be ≥ 21 days from the administration of any prior cytotoxic therapy (including chemotherapy).
* At the time of starting protocol therapy, subjects must be ≥ 28 days from any radiation or proton therapy.
* At the time of starting protocol therapy, subjects must be ≥ 28 days from administration of antibody-based immune checkpoint-inhibitor therapies, tumor-directed vaccines, or cellular immune thera…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.
Timeframe: Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.