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Can a new drug combo fight childhood brain tumors that Won't stop growing?

NCT ID NCT07732413

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

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

5 to 21 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Augusta University, Georgia Cancer Center

    Augusta, Georgia, 30912, United States

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