NCT06614855

A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: James Markert, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is divided into the following sections, also called phases: the Initial Screening Phase, Initial Treatment Phase, Initial Treatment Follow-up Phase, 2nd Treatment Screening Phase, 2nd Treatment Phase, 2nd Treatment Follow-up Phase. Before the subject can participate in the study, tests will be performed to make sure that the subject qualifies for the study. This is called the Initial Screening Phase. If the subject qualifies for the study they will then enter the Initial Treatment Phase which is the phase where they will receive the study drug and then enter the Initial Follow-up Phase. If there are signs of progression, the subject will be entered into the 2nd Treatment Phase.

Conditions

• Glioblastoma
• Glioblastoma (GBM)
• Astrocytoma
• Astrocytoma, Grade III
• Astrocytoma, Grade IV
• Gliosarcoma, Adult
• Gliosarcoma of Brain

Interventions

Type	Name	Description
DRUG	C134	Initial Treatment . C134 Dose #1
DRUG	C134	2nd Treatment. C134 Dose #2

Timeline

• Start date: 2025-06-02
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-09-26
• Last updated: 2025-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study