Phase 2 Trial of G207 + 5 Gy Radiation for Children With High-Grade Gliomas

NCT07649070 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2026-0432NCI-2026-04556
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn about the safety and effects of G207 combined with radiation therapy in patients with recurrent or progressive high-grade glioma (HGG).

Conditions

High Grade Gliomas

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with G207 (IT) + 5 Gy Radiation

EXPERIMENTAL

Treatment will be administered on a inpatient basis.

Drug: G207

Interventions

G207 DRUG

Given by injection

Treatment with G207 (IT) + 5 Gy Radiation

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Pregnancy
• Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects.
• Lactation Status
• Lactating females are not eligible unless they have agreed not to breastfeed their infants
• Because there is an unknown potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
• Patients with primary tumor involving the cerebellum, brainstem or spinal cord, or that would require surgical access through a ventricle to deliver the prescribed protocol treatment.
• Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain.
• Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation.
• Concurrent Illness
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to undergo surgery and/or tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
• Known HIV seropositivity.
• Diagnosis of encephalitis or CNS infection \< 12 weeks prior, or receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis.
• Concurrent Medications

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

Study Officials

• Gregory Friedman, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Friedman, MD

CONTACT

713-557-4400; gkfriedman@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (1)