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NLG802 and Temozolomide for Pediatric Brain Cancer

This study is testing a new drug called NLG802 in combination with an existing chemotherapy, temozolomide, for children and young adults (ages 5-21) with progressive brain or spinal cancer. NLG802 is designed to block a protein called IDO1, which may help the body fight cancer. The main goal of this Phase 1 study is to find the highest safe dose of NLG802 when given with temozolomide. To join, you must have a brain or spinal tumor that has come back or isn't responding to other treatments, and tumor tissue is needed for review. The study is currently unclear on its recruitment status, but plans to enroll 30 participants.

Study design
This is an open-label Phase 1 study, meaning everyone knows what treatments are being given. It will enroll about 30 participants to find the maximum tolerated dose of NLG802 in combination with temozolomide.
What's involved
Participants will take NLG802 by mouth twice daily and temozolomide by mouth once daily for 5 days, throughout each treatment cycle. Blood draws will be taken in the first cycle to see how the body processes NLG802.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, maximum tolerated dose, is measured at the end of Cycle 1, which is 28 days plus any delay before starting Cycle 2.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07732413

Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer

Not Yet Recruiting
PHASE1Ages 5–21InterventionalTreatment
Lumos Pharma
~30 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:NLG802 (indoximod Prodrug)Temozolomide

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.
Measured over Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.

Conditions

Progressive Pediatric Brain Cancer

Explore related trials

Malignant Brain NeoplasmSpinal MalignancyIDO1 Gene

Where it's being run

1 sites across 1 states
Georgia1

Who to contact

Lumos Pharma
[email protected]
515-296-5555
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.

    Determined by number of patients with dose limiting toxicities.