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Progressive Pediatric Brain CancerPhase 1NCT07732413

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

A Phase 1 study testing NLG802 (indoximod Prodrug) and Temozolomide in people with Progressive Pediatric Brain Cancer, run by Lumos Pharma at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 21 years
Conditions the study is for
Progressive Pediatric Brain Cancer
What is being tested?
NLG802 (indoximod Prodrug) and Temozolomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
8 Oct 2026to 8 Oct 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
Show all 22Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lumos Pharma contact

515-296-5555

clinical.trials@lumos-pharma.com

United States1 site

  • Augusta University, Georgia Cancer Center

    Augusta, Georgia, 30912

    Theodore S. Johnson, MD, PhD, 706-721-4962, thjohnson@augusta.edu

    Robin Dobbins, RN, 706-721-2154, rdobbins@augusta.edu

Other trials in United States

About this study

Official title: Phase 1b Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer

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.

Read the detailed description

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 toxicity-related delay before starting Cycle 2. Toxicity will be defined and graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. All subjects will have timed blood draws for NLG802 pharmacokinetic (PK) analysis in Cycle 1.

Being tested
NLG802 (indoximod Prodrug), Temozolomide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NLG802 (indoximod Prodrug)Drug

    NLG802 will be taken by mouth twice daily, throughout each treatment cycle.

  • TemozolomideDrug

    Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.

Study groups in NCT07732413
Study groupRoleWhat they receive
NLG802 indoximod prodrug in combination with temozolomideExperimentalNot described
Receives: Drug: NLG802 (indoximod Prodrug); Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide.

    Determined by number of patients with dose limiting toxicities.

    Measured: Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.

Secondary outcomes (5)

  1. Incidence of Regimen-limiting toxicities in in pediatric participants for NLG802 in combination with temozolomide.

    Determined by number of patients with regimen limiting toxicities.

    Measured: Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.

  2. Pharmacokinetics in pediatric participants for NLG802 in combination with temozolomide

    Serum concentrations (Cmax/Steady State).

    Measured: Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.

  3. Overall survival for NLG802 in combination with temozolomide.

    Measured: Day 1 up to 12 months.

  4. Evidence of efficacy for NLG802 in combination with temozolomide based on change to objective response rate.

    Measured by subjects who achieve complete response, partial response or no response.

    Measured: Day 1 up to 12 months.

  5. Percentage of patients with adverse events

    Assessment of safety and tolerability of NLG802 in combination with temozolomide.

    Measured: Day 1 up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start8 Oct 2026 (estimated)
  3. Primary completion8 Oct 2030 (estimated)
  4. Study completion8 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732413
Sponsor's protocol ID
NLG8022
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
28 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NLG802 (indoximod Prodrug) and Temozolomide in people with Progressive Pediatric Brain Cancer, run by Lumos Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lumos Pharma (515-296-5555, clinical.trials@lumos-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose in pediatric participants for NLG802 in combination with temozolomide. (time frame: Cycle 1, which will be 28 days duration plus any toxicity-related delay before starting Cycle 2.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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