Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG) (NCT07389278) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
United States97 participantsStarted 2026-03-09
Plain-language summary
This is an open label, intra-patient dose escalation, to evaluate ADI-PEG 20, in combination with Temozolomide (TMZ) and radiation therapy (RT) in children, adolescents and young adult patients with newly diagnosed high grade glioma (HGG).
Who can participate
Age range3 Years – 39 Years
SexALL
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Inclusion criteria
✓. Participants must have histologically and molecularly confirmed newly diagnosed World Health Organization (WHO) grade 3 or 4 glioma.
✓. Phase 1: any newly diagnosed HGG (including DMG of any location and primary spinal cord tumors).
✓. Phase 2:
✓. Prior surgery: must have undergone maximal safe resection. For patients with DMG of the pons, biopsy is sufficient.
✓. Prior Therapy: Participants must NOT have received ANY prior therapy (except surgery) before enrollment on study.
✓. Tumor Tissue Requirement: Participants must have sufficient tumor tissue (5-10 unstained formalin-fixed paraffin-embedded (FFPE) slides or a tumor block) for study enrollment.
✓. Age:
✓. Performance Score: Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants \<=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Exclusion criteria
✕. Participants who have received any systemic therapy or RT, including any investigational agents.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20 such as pegylated compounds.
✕. Phase 2 cohorts: tumors with epicenter in pons or spinal cord
What they're measuring
1
Proportion of participants with Treatment-emergent Adverse Events (TrAE) (Phase 1)
Timeframe: Up to 104 weeks
2
Progression-Free Survival (PFS) for HGG histone-WT (Phase 2, Cohort 1)
✕. Participants with metastatic or leptomeningeal disease. Multi-focal disease should be discussed with the study chairs,
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection that would interfere with the study.
✕. Women of childbearing potential must not be pregnant or breast-feeding.
✕. Human immunodeficiency virus (HIV)-positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised.