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ACTIVE NOT RECRUITING Phase 1

D2C7-IT With Atezolizumab for Recurrent Gliomas

NCT04160494 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2020-02-25
Est. Completion 2027-12
Phase Phase 1

Sponsor

Darell Bigner

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04160494

The ClinicalTrials.gov registry entry for NCT04160494 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Darell Bigner, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04160494 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04160494?

This trial is sponsored by Darell Bigner, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial