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High Grade GliomasPhase 2NCT07649070

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

A Phase 2 study testing G207 in people with High Grade Gliomas, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 3 to 21 years
Conditions the study is for
High Grade Gliomas
What is being tested?
G207
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
12 Oct 2026to 31 Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

None listed.

Who cannot join

  • 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.
Show all 23Show fewer
  • Disease-Related Exclusion Criteria
  • 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
  • Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
  • Patients who are receiving ≥ 2 mg of dexamethasone (or ≥ 10 mg of prednisone) daily
  • Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation
  • For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency), intermittent use of bronchodilators and topical steroids, is not considered immunosuppressive and does not constitute exclusion.
  • Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).
  • Inability to Participate
  • Patients who in the opinion of the investigator are unwilling or unable to return for required followup visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to the drug administration plan, other study procedures, and study restrictions.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gregory Friedman, MD contact

713-557-4400

gkfriedman@mdanderson.org

United States1 site, 1 recruiting

  • UT MD Anderson

    Houston, Texas, 77030

    Gregory Friedman, MD, 713-557-4400, gkfriedman@mdanderson.org

    Gregory Friedman, MD

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

Primary Objective:

To assess the efficacy of G207 administered intratumorally followed by 5 Gy radiation within 24hours in patients with recurrent or progressive high-grade glioma (HGG) as measured by postprogression overall survival (pp-OS), focused on patients with one progression following their priorsurgery and radiotherapy, compared to matched historical controls.

Secondary Objectives:

To describe the pp-OS survival in patients treated with G207 + 5 Gy with more than one progression following their prior surgery and radiotherapy

To establish safety and characterize toxicity of G207 + 5 Gy radiation

To survey for virologic shedding following G207

To evaluate immunologic response(s) to G207

To assess radiographic changes from baseline by RANO 2.0 criteria and by tumor volume, cerebral blood volume, and apparent diffusion coefficient.

To describe the efficacy of G207 + 5 Gy radiation as measured by response rate and progressionfree survival (PFS)

Exploratory Objectives:

To assess performance status score changes over time after treatment with G207 + 5 Gy radiation

To evaluate pre- and post-treatment tissue for immune cell populations and checkpoint proteins in patients who are amendable to and meet criteria for resection/biopsy while on study

To assess OS in subgroups of patients based on therapies received after G207 + 5 Gy radiation (surgery versus no surgery; reirradiation versus no reirradiation, immunotherapy versus no immunotherapy)

Being tested
G207

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G207Drug

    Given by injection

Study groups in NCT07649070
Study groupRoleWhat they receive
Treatment with G207 (IT) + 5 Gy RadiationExperimentalTreatment will be administered on a inpatient basis.
Receives: Drug: G207

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start12 Oct 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07649070
Sponsor's protocol ID
2026-0432
Other IDs
NCI-2026-04556
Status last verified
Oct 2026
First submitted
12 Jun 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G207 in people with High Grade Gliomas, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gregory Friedman, MD (713-557-4400, gkfriedman@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07649070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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