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

Part of paid clinical trials in San Francisco, California.

Sponsor
Sabine Mueller, MD, PhD
Study ID
NCT07389278
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI-PEG 20 (Arginine deiminase pegylated) — DRUG
    Given intramuscularly (IM)
  • Temozolomide (TMZ) — DRUG
    Given orally (PO)
  • Standard of Care Radiation Therapy (RT) — RADIATION
    Undergo RT

Study Details

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).

Key Dates

Start date
Mar 9, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2032
Completion
Jun 30, 2035

Study Design

Enrollment
97 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Starting Dose: ADI-PEG 20 36mg/m^2)
    Participants will receive injection of 36 mg/m\^2 of ADI-PEG 20 once weekly in the concomitant phase and maintenance phases given prior to the start of RT. Participants will also receive daily oral (PO) temozolomide (TMZ) with dosage based on age and dosing phase (concomitant, then maintenance) starting on the same day as Radiotherapy (RT). RT will be given in standard fractions (total dose 59.4 Gy) over 6 weeks. The boost volume, when present, will receive an additional 5.4 Gy for a total of 59.4 Gy. Post-RT, Participants will continue to receive weekly ADI-PEG 20 as monotherapy and then proceed to first cycle of maintenance therapy 28 days (+7 days) after completion of RT, in the absence of dose-limiting toxicities (DLT) or progressive disease. The maintenance phase consists of ten cycles (28 days long) of combination chemotherapy with ADI-PEG 20 and TMZ. Participants will receive no more than 104 weeks of ADI-PEG 20 therapy
  • Experimental: Phase 2 (Cohort 1) - Histone Wild Type (WT) HGG
    Participants with WT HGG will be treated at the recommended phase 2 dose (RP2D) of ADI-PEG 20 determined in Phase 1 in combination with TMZ. Participants who complete the combined treatment and maintenance phase may continue receiving monotherapy treatment as extended maintenance for up to 10 additional cycles, provided there is no unacceptable toxicity, disease progression, or withdrawal of consent. ADI-PEG 20 treatment may continue for up to 104 weeks.
  • Experimental: Phase 2 (Cohort 2) - H3K27 Altered Diffuse Midline Gliomas (DMG)
    Participants will be treated at the recommended phase 2 dose (RP2D) of ADI-PEG 20 determined in Phase 1. Participants who complete the combined treatment and maintenance phase may continue receiving monotherapy treatment as extended maintenance for up to 10 additional cycles, provided there is no unacceptable toxicity, disease progression, or withdrawal of consent. ADI-PEG 20 treatment may continue for up to 104 weeks. After completing the 30-day toxicity evaluation period, participants will enter follow-up. Follow-up procedures will be documented under the PNOC COMP protocol, except for protocol-defined follow-up procedures. Participants will be followed under the PNOC COMP protocol until death or withdrawal from the study.
  • Experimental: Phase 2 (Cohort 3) - H3G34 Mutant Diffuse Hemispheric Gliomas (DHG)
    Participants will be treated at the recommended phase 2 dose (RP2D) of ADI-PEG 20 determined in Phase 1. Participants who complete the combined treatment and maintenance phase may continue receiving monotherapy treatment as extended maintenance for up to 10 additional cycles, provided there is no unacceptable toxicity, disease progression, or withdrawal of consent. ADI-PEG 20 treatment may continue for up to 104 weeks. After completing the 30-day toxicity evaluation period, participants will enter follow-up. Follow-up procedures will be documented under the PNOC COMP protocol, except for protocol-defined follow-up procedures. Participants will be followed under the PNOC COMP protocol until death or withdrawal from the study.

Primary Outcome Measure

Proportion of participants with Treatment-emergent Adverse Events (TrAE) (Phase 1) [ Time Frame: Up to 104 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations Office
[email protected]
415-502-1600
Sabine Mueller, MD, PhD (PRINCIPAL_INVESTIGATOR)

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