MedTrace Logo

Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)

NCT07389278 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-02-05

No results posted yet for this study

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).

Conditions

  • Glioblastoma
  • High-Grade Glioma (WHO III-IV)
  • High-grade Glioma
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Diffuse Hemispheric Glioma, H3G34 Mutant

Interventions

DRUG

ADI-PEG 20 (Arginine deiminase pegylated)

Given intramuscularly (IM)

DRUG

Temozolomide (TMZ)

Given orally (PO)

RADIATION

Standard of Care Radiation Therapy (RT)

Undergo RT

Sponsors & Collaborators

  • Sabine Mueller, MD, PhD

    lead OTHER

Principal Investigators

  • Sabine Mueller, MD, PhD · University of California, San Francisco

  • Tom Davidson, MD · Children's Hospital Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2032-06-30
Completion
2035-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07389278 on ClinicalTrials.gov