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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Lumos Pharma
Study ID
NCT07732413
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Progressive Pediatric Brain Cancer

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • NLG802 (indoximod Prodrug) — DRUG
    NLG802 will be taken by mouth twice daily, throughout each treatment cycle.
  • Temozolomide — DRUG
    Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Oct 8, 2026
Status verified
Jul 2026
Primary completion
Oct 8, 2030
Completion
Oct 8, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: NLG802 indoximod prodrug in combination with temozolomide

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Augusta University, Georgia Cancer CenterAugustaGeorgia30912
Theodore S. Johnson, MD, PhD
[email protected]
706-721-4962
Robin Dobbins, RN
[email protected]
706-721-2154
Theodore S. Johnson, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Augusta University, Georgia Cancer Center· Augusta, GA