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NCT04547777 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
A Phase 1 study of Glioma, Malignant, sponsored by Darell Bigner.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT04547777: Recruiting Phase 1 study of Glioma, Malignant, sponsored by Darell Bigner.
NCT04547777 is a Phase 1 study of Glioma, Malignant that is actively recruiting participants, run by Darell Bigner. The registered enrollment target is 90 participants, above the 59-participant average among 19 other Glioma, Malignant trials with a reported enrollment target (53% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04547777, a Phase 1 study of Glioma, Malignant, is actively recruiting participants, sponsored by Darell Bigner.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
Primary Outcome
DLTs are defined as any of the following events that are at least possibly, probably, or definitely attributable to study treatment (2141-V11 or the combination of D2C7-IT and 2141-V11) during dose escalation. As the optimal dose of D2C7-IT in monotherapy has been well established, only toxicity starting or increasing in grade at any time after the start of 2141-V11 will be considered for DLT definition.
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 | 90 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT04547777 shows while recruiting
NCT04547777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 59-participant average among 19 other Glioma, Malignant trials with a reported enrollment target (53% higher).
The record links to 1 condition, with Glioma, Malignant appearing as the primary indexed condition, and to 2 interventions - of which D2C7-IT is the first listed.
NCT04547777 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04547777 about?
NCT04547777 is a clinical study titled "Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma". This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
What is the current status of trial NCT04547777?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2021-07-09. Estimated completion is 2027-06.
What conditions does trial NCT04547777 study?
This clinical trial studies the following conditions: Glioma, Malignant.
What interventions are being tested in trial NCT04547777?
The interventions under investigation include: D2C7-IT (DRUG), 2141-V11 (DRUG).
Who is sponsoring clinical trial NCT04547777?
This trial is sponsored by Darell Bigner, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04547777 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 Glioma, Malignant
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 NCT04547777's enrollment target sits among peer trials
90 4th of 19 higher than 16 of 19 other Glioma, Malignant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioma, Malignant 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.
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