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NCT05283109 · ClinicalTrials.gov registry record · Phase 1
ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM
A Phase 1 study of Glioma, Malignant, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05283109: Active Phase 1 study of Glioma, Malignant, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
NCT05283109 is a Phase 1 study of Glioma, Malignant that is active but no longer recruiting, run by Mustafa Khasraw, MBChB, MD, FRCP, FRACP. The registered enrollment target is 24 participants, below the 62-participant average among 19 other Glioma, Malignant trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05283109, a Phase 1 study of Glioma, Malignant, is active but no longer recruiting, sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A\*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.
Primary Outcome
A dose-limiting toxicity (DLT) is as an unacceptable toxicity, based on CTCAE v5.0, that occurs during the DLT observation period that extends between date of vaccine #1 (Day 1) and 30 days after vaccine #5 (Day 22). Any ≥ Grade 3 AEs were to be considered as unacceptable toxicities if they were possibly, probably, or definitely attributable to the protocol treatment regimen, and if they occurred within 30 days of vaccination. Specifically, any ≥ Grade 3 organ toxicity (cardiac, renal, hepatic),
Conditions Studied
Interventions
- BIOLOGICAL Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine
- DRUG Hiltonol
Study Locations (1)
North Carolina
- The Preston Robert Tisch Brain Tumor Center at Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 1 |
What the registry record for NCT05283109 still lists
NCT05283109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 62-participant average among 19 other Glioma, Malignant trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Glioma, Malignant appearing as the primary indexed condition, and to 2 interventions - of which Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine is the first listed.
NCT05283109 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05283109 about?
NCT05283109 is a clinical study titled "ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM". This is a phase 1b study of P30-linked EphA2, CMV pp65, and survivin vaccination (collectively called the P30-EPS vaccine) in HLA-A\*0201 positive patients with a newly diagnosed, unmethylated, and untreated World Health Organization (WHO) grade IV malignant glioma.
What is the current status of trial NCT05283109?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-08-30. Estimated completion is 2028-02-28.
What conditions does trial NCT05283109 study?
This clinical trial studies the following conditions: Glioma, Malignant.
What interventions are being tested in trial NCT05283109?
The interventions under investigation include: Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine (BIOLOGICAL), Hiltonol (DRUG).
Who is sponsoring clinical trial NCT05283109?
This trial is sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05283109 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
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Where NCT05283109's enrollment target sits among peer trials
24 12th of 19 higher than 8 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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