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NCT05734560 · ClinicalTrials.gov registry record · Phase 1
D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients
A Phase 1 study of Newly Diagnosed MGMT Unmethylated Glioblastoma, sponsored by Darell Bigner.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05734560 is a Phase 1 study of Newly Diagnosed MGMT Unmethylated Glioblastoma that is actively recruiting participants, run by Darell Bigner. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05734560, a Phase 1 study of Newly Diagnosed MGMT Unmethylated Glioblastoma, is actively recruiting participants, sponsored by Darell Bigner.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).
Conditions Studied
Interventions
- DRUG D2C7-IT
- DRUG 2141-V11
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-09-06 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05734560
The ClinicalTrials.gov registry entry for NCT05734560 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Darell Bigner, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Newly Diagnosed MGMT Unmethylated Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which D2C7-IT is the first listed.
NCT05734560 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT05734560 about?
NCT05734560 is a clinical study titled "D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients". The purpose of this research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injec...
What is the current status of trial NCT05734560?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-09-06. Estimated completion is 2028-10-31.
What conditions does trial NCT05734560 study?
This clinical trial studies the following conditions: Newly Diagnosed MGMT Unmethylated Glioblastoma.
What interventions are being tested in trial NCT05734560?
The interventions under investigation include: D2C7-IT (DRUG), 2141-V11 (DRUG).
Who is sponsoring clinical trial NCT05734560?
This trial is sponsored by Darell Bigner, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05734560 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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