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

NCT07732413 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-28

No results posted yet for this study

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

Interventions

DRUG

NLG802 (indoximod Prodrug)

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

DRUG

Temozolomide

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

Sponsors & Collaborators

  • Lumos Pharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-08
Primary Completion
2030-10-08
Completion
2030-10-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07732413 on ClinicalTrials.gov