Can a new drug combo fight childhood brain tumors that Won't stop growing?
NCT ID NCT07732413
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether an experimental drug called NLG802, taken as a pill, can be safely combined with the chemotherapy drug temozolomide for children and young adults (ages 5 to 21) with progressive brain or spinal cord cancer. The study aims to find the highest safe dose of the combination and to understand how the body processes the drugs. Participants must have a tumor that has returned or not responded to prior treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called NLG802 (indoximod prodrug) taken by mouth, combined with the chemotherapy drug temozolomide
- What this could lead to
- If it works, this could point toward a new treatment option for children with brain tumors that have stopped responding to standard therapy.
- What could go wrong
- This is an early-phase trial with only 30 participants, so the drug may not prove safe or effective. Side effects from the combination are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 therapies. * At the time of starting protocol therapy, subjects must be ≥ 56 days from administration of tumor-directed therapies using infectious agents. * At the time of starting protocol therapy, subjects must be ≥ 90 days from a stem cell transplant with growth-factor independent recovery of adequate bone marrow function. * Subjects, or their parent for subjects \< 18 years of age, must sign an Informed Consent Form (ICF) indicating that they understand the purpose of the trial and procedures required, including biomarkers, and are willing to participate in the trial. Exclusion Criteria: * 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. * Active systemic infection requiring treatment. * Active autoimmune disease that requires systemic therapy. * Any known bleeding diathesis. * Subjects who are breastfeeding or pregnant women.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Augusta University, Georgia Cancer Center
Augusta, Georgia, 30912, United States
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