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

NCT06614855 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-06

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

C134

Initial Treatment . C134 Dose #1

DRUG

C134

2nd Treatment. C134 Dose #2

Sponsors & Collaborators

  • James Markert, MD

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2027-01-01
Completion
2028-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06614855 on ClinicalTrials.gov