Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04160494 · ClinicalTrials.gov registry record · Phase 1
D2C7-IT With Atezolizumab for Recurrent Gliomas
A Phase 1 study of Malignant Glioma, sponsored by Darell Bigner.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04160494: Active Phase 1 study of Malignant Glioma, sponsored by Darell Bigner.
NCT04160494 is a Phase 1 study of Malignant Glioma that is active but no longer recruiting, run by Darell Bigner. The registered enrollment target is 18 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04160494, a Phase 1 study of Malignant Glioma, is active but no longer recruiting, sponsored by Darell Bigner.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1 study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Primary Outcome
An unacceptable adverse event includes any Grade 3 or any Grade 4 toxicity that is not reversible within 2 weeks, any life-threatening event, or any treatment-related death. Also included are any grade 2 or higher serious autoimmune toxicities, particularly those affecting vital organs (e.g. cardiac, renal, CNS) if it occurs within 2 weeks of any protocol treatment.
Conditions Studied
Interventions
- DRUG D2C7-IT (6920 ng/mL via convection-enhanced delivery)
- DRUG Atezolizumab (1200 mg every three weeks)
- DRUG D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-02-25 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What the registry record for NCT04160494 still lists
NCT04160494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Malignant Glioma appearing as the primary indexed condition, and to 3 interventions - of which D2C7-IT (6920 ng/mL via convection-enhanced delivery) is the first listed.
NCT04160494 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04160494 about?
NCT04160494 is a clinical study titled "D2C7-IT With Atezolizumab for Recurrent Gliomas". This is a phase 1 study of atezolizumab in combination with D2C7-IT, a dual-specific monoclonal antibody (mAB) with a high affinity for both EGFRwt- and EGFRvIII-expressing cells, in patients with recurrent World Health Organization (WHO) grade IV malignant glioma at the Preston Robert Tisch Brain T...
What is the current status of trial NCT04160494?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-02-25. Estimated completion is 2027-12.
What conditions does trial NCT04160494 study?
This clinical trial studies the following conditions: Malignant Glioma.
What interventions are being tested in trial NCT04160494?
The interventions under investigation include: D2C7-IT (6920 ng/mL via convection-enhanced delivery) (DRUG), Atezolizumab (1200 mg every three weeks) (DRUG), D2C7-IT (4613.2 ng/mL via convection-enhanced delivery) (DRUG).
Who is sponsoring clinical trial NCT04160494?
This trial is sponsored by Darell Bigner, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04160494 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04160494's enrollment target sits among peer trials
18 36th of 40 higher than 3 of 40 other Malignant Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Glioma 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
-
CARv3-TEAM-E T Cells in Glioblastoma
RECRUITING · Phase 1
-
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
RECRUITING · Phase 1
-
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
RECRUITING · Phase 1
-
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
RECRUITING · Phase 1
-
Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Trial
RECRUITING · Phase 1
-
BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas
ACTIVE NOT RECRUITING · Phase 1
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
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
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