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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 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.

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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.

Interventions

  • DRUG C134

Study Locations (1)

Alabama

  • The University of Alabama at Birmingham Hospital - Birmingham

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2025-06-02
Est. Completion 2028-01-01
Phase Phase 1

Sponsor

James Markert, MD

1 total trials

What the Registry Record Tells You About NCT06614855

The ClinicalTrials.gov registry entry for NCT06614855 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (89% lower). The listed sponsor is James Markert, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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