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NCT06614855 · ClinicalTrials.gov registry record · Phase 1
A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma
A Phase 1 study of Glioblastoma and Astrocytoma, sponsored by James Markert, MD.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06614855: Active Phase 1 study of Glioblastoma and Astrocytoma, sponsored by James Markert, MD.
NCT06614855 is a Phase 1 study of Glioblastoma and Astrocytoma that is active but no longer recruiting, run by James Markert, MD. The registered enrollment target is 12 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06614855, a Phase 1 study of Glioblastoma and Astrocytoma, is active but no longer recruiting, sponsored by James Markert, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when administered twice into the brain where the tumor is located. This is a Phase IB 2 dosing study. All the patients who take part in this study will receive the same type of experimental treatment. There is no "placebo" in this study. The patient will receive the dose of C134 administered, which will be added in the tumor infiltrated tissue in the area of the resection cavity. Anywhere from 4-12 patients are expected to take part in the study; the final number will depend on the safety results.
Primary Outcome
Adverse events will be monitored and any changes in status will be recorded for each patient as outlined in CTCAE v4.0 reporting requirements.
Conditions Studied
Interventions
- DRUG C134
Study Locations (1)
Alabama
- The University of Alabama at Birmingham Hospital - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 1 |
What the registry record for NCT06614855 still lists
NCT06614855 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (89% lower).
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which C134 is the first listed.
NCT06614855 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06614855 about?
NCT06614855 is a clinical study titled "A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma". The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when administered twice into the brain where the tumor is located. This is a Phase IB 2 dosing study. All the patients who take part in this study will receive the same type of experimental...
What is the current status of trial NCT06614855?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-06-02. Estimated completion is 2028-01-01.
What conditions does trial NCT06614855 study?
This clinical trial studies the following conditions: Glioblastoma, Astrocytoma, Glioblastoma (GBM), Astrocytoma, Grade IV, Astrocytoma, Grade III.
What interventions are being tested in trial NCT06614855?
The interventions under investigation include: C134 (DRUG).
Who is sponsoring clinical trial NCT06614855?
This trial is sponsored by James Markert, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06614855 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
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 NCT06614855's enrollment target sits among peer trials
12 180th of 199 higher than 13 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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
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