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

NCT07732413 | Not Yet Recruiting Phase 1

• 1 other identifier: NLG8022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Progressive Pediatric Brain Cancer

Outcome Measures

Primary Outcomes (1)

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

  Determined by number of patients with dose limiting toxicities.

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

Secondary Outcomes (5)

• Incidence of Regimen-limiting toxicities in 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.

• Pharmacokinetics 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.

• Overall survival for NLG802 in combination with temozolomide.

  Day 1 up to 12 months.

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

  Day 1 up to 12 months.

• Percentage of patients with adverse events

  Day 1 up to 12 months.

Study Arms (1)

NLG802 indoximod prodrug in combination with temozolomide

EXPERIMENTAL

Drug: NLG802 (indoximod Prodrug); Drug: Temozolomide

Interventions

NLG802 (indoximod Prodrug) DRUG

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

NLG802 indoximod prodrug in combination with temozolomide

Temozolomide DRUG

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

NLG802 indoximod prodrug in combination with temozolomide

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lumos Pharma: lead

Study Sites (1)

Augusta University, Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Lumos Pharma

CONTACT

515-296-5555; clinical.trials@lumos-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): October 8, 2030
• Study Completion (Estimated): October 8, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

US (1)