Diffuse Midline Glioma, H3 K27M-MutantPhase 2NCT07589257
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
A Phase 2 study testing VRT106 for injection in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
- What is being tested?
- VRT106 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2026to 31 Dec 2028
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signing of the Informed Consent Form (ICF), indicating understanding of the study and willingness and ability to comply with all study procedures.
- Male or female adults aged 18 to 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed H3 K27-altered diffuse midline glioma (DMG), or a diagnosis of DIPG based on brain contrast-enhanced MRI: tumor originating in the pons, occupying >50% of the pons volume, with diffuse brainstem enlargement.
- Karnofsky Performance Status (KPS) score ≥ 60.
- Expected survival time ≥ 3 months.
Who cannot join
- Individuals with extracranial metastases.
- Presence of spinal cord tumors or evidence of leptomeningeal disease dissemination.
- Active hemorrhage detected on cranial MRI scan prior to enrollment.
- Inability to undergo cranial MRI scanning (e.g., due to contraindications or incompatible implants).
- Prior receipt of oncolytic virus therapy or other gene therapy agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Yuanyuan Chen, 202-87343543, chenyy2@sysucc.org.cn
About this study
Official title: A Single-Arm, Open-Label, Multicenter Phase II Clinical Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Including Diffuse Intrinsic Pontine Glioma
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
Read the detailed description
This is a single-arm, open-label, multicenter Phase II study designed to assess the efficacy, safety, pharmacokinetic (PK) profile, and biological effects of VRT106 combined with radiotherapy in adult patients with newly diagnosed or progressive diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG).
- Being tested
- VRT106 for injection
- Keywords
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT106 for injectionDrug
VRT106, iv
| Study group | Role | What they receive |
|---|---|---|
| VRT106 | Experimental | VRT106 Receives: Drug: VRT106 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Evaluations will be performed at 6 weeks (± 3 days) following the completion of radiotherapy, subsequently every 9 weeks (± 7 days) during the first year of treatment, and then every 12 weeks (± 7 days) thereafter.
Measured: About 2 years
Secondary outcomes (2)
Progression-Free Survival
Evaluations will be performed at 6 weeks (± 3 days) following the completion of radiotherapy, subsequently every 9 weeks (± 7 days) during the first year of treatment, and then every 12 weeks (± 7 days) thereafter.
Measured: About 2 years
Overall survival
Time from initial administration to death.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start7 May 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Midline Glioma, H3 K27M-MutantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuanyuan Chen, Study chair, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589257
- Sponsor's protocol ID
- VRT106-CN06
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multicenter Phase II Clinical Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Including Diffuse Intrinsic Pontine Glioma
- ClinicalTrials.gov ID
- NCT07589257
- Acronym / sponsor ID
- VRT106-CN06
- Keywords
- Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
Detailed description
This is a single-arm, open-label, multicenter Phase II study designed to assess the efficacy, safety, pharmacokinetic (PK) profile, and biological effects of VRT106 combined with radiotherapy in adult patients with newly diagnosed or progressive diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRT106 | Experimental | Drug: VRT106 for injectionVRT106 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntary signing of the Informed Consent Form (ICF), indicating understanding of the study and willingness and ability to comply with all study procedures.
- Male or female adults aged 18 to 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed H3 K27-altered diffuse midline glioma (DMG), or a diagnosis of DIPG based on brain contrast-enhanced MRI: tumor originating in the pons, occupying >50% of the pons volume, with diffuse brainstem enlargement.
- Karnofsky Performance Status (KPS) score ≥ 60.
- Expected survival time ≥ 3 months.
Key exclusion criteria (5 listed)
- Individuals with extracranial metastases.
- Presence of spinal cord tumors or evidence of leptomeningeal disease dissemination.
- Active hemorrhage detected on cranial MRI scan prior to enrollment.
- Inability to undergo cranial MRI scanning (e.g., due to contraindications or incompatible implants).
- Prior receipt of oncolytic virus therapy or other gene therapy agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRT106 for injectionVRT106, iv | Drug | VRT106 |
Primary outcome
Disease Control Rate
Time frame: About 2 years
Evaluations will be performed at 6 weeks (± 3 days) following the completion of radiotherapy, subsequently every 9 weeks (± 7 days) during the first year of treatment, and then every 12 weeks (± 7 days) thereafter.
2 secondary outcomes
Progression-Free Survival
Time frame: About 2 years
Overall survival
Time frame: About 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanyuan Chen study chair
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VRT106 for injection in people with Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
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 5 inclusion and 5 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 30 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 China. 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 Yuanyuan Chen (202-87343543, chenyy2@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.