Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07389278 · ClinicalTrials.gov registry record · Phase 1
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
A Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
- Not yet
- Registry status
- Phase 1
- Development phase
- 97
- Enrollment target
NCT07389278: Clinical Trial Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
NCT07389278 is a Phase 1 study that has not yet begun recruiting, run by Sabine Mueller, MD, PhD. The registered enrollment target is 97 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07389278, a Phase 1 study, has not yet begun recruiting, sponsored by Sabine Mueller, MD, PhD.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 97 participants
- Enrollment target
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).
Primary Outcome
Proportion of participants in Phase 1 with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be reported.
Interventions
- DRUG Temozolomide (TMZ)
- DRUG ADI-PEG 20 (Arginine deiminase pegylated)
- RADIATION Standard of Care Radiation Therapy (RT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2026-03-09 |
| Est. Completion | 2035-06-30 |
| Phase | Phase 1 |
What is known before NCT07389278 opens enrollment
NCT07389278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 3 interventions - of which Temozolomide (TMZ) is the first listed.
NCT07389278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07389278 about?
NCT07389278 is a clinical study titled "Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)". 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).
What is the current status of trial NCT07389278?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2026-03-09. Estimated completion is 2035-06-30.
What interventions are being tested in trial NCT07389278?
The interventions under investigation include: Temozolomide (TMZ) (DRUG), ADI-PEG 20 (Arginine deiminase pegylated) (DRUG), Standard of Care Radiation Therapy (RT) (RADIATION).
Who is sponsoring clinical trial NCT07389278?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07389278's enrollment target sits among peer trials
97 597th of 2000 higher than 1,401 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03948490 · 97 participants · NA
Rehabilitation and Longitudinal Follow-up of Cognition in Adult Lower Grade Gliomas
- NCT04140487 · 97 participants · Phase 1
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- NCT04196413 · 97 participants · Phase 1
GD2 CAR T Cells in Diffuse Intrinsic Pontine Gliomas (DIPG) & Spinal Diffuse Midline Glioma(DMG)
- NCT05223816 · 97 participants · Phase 2
An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI