Actively Recruiting
A Single-Arm, Open-Label Phase II Study of VRT106 Combined With Radiotherapy in Adults With Diffuse Midline Glioma Including Diffuse Intrinsic Pontine Glioma
Led by Guangzhou Virotech Pharmaceutical Co., Ltd. · Updated on 2026-05-15
10
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preliminary efficacy and safety of VRT106 combined with radiotherapy in adult patients who have diffuse midline glioma (DMG) or diffuse intrinsic pontine glioma (DIPG). This Phase II study is designed to assess how this combination treatment affects patients with newly diagnosed or progressive forms of these serious brain tumors. Participants will receive VRT106 administered by injection along with radiotherapy. This single-arm, open-label study takes place at multiple centers and focuses on understanding the pharmacokinetics and biological effects of the combined treatment. The study does not include a comparison group and evaluates all participants under the same treatment plan. Throughout the study, participants will be monitored for disease control, progression-free survival, and overall survival over about two years. Assessments include safety, tolerability, and pharmacokinetic evaluations, along with brain imaging and clinical exams. The study lasts approximately two years, during which researchers will carefully track how patients respond to the treatment and collect data to inform future therapies.
CONDITIONS
Brief Title
A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary signing of the Informed Consent Form (ICF)
- Adults aged 18 to 75 years
- Histologically or cytologically confirmed H3 K27-altered diffuse midline glioma, or diagnosis of DIPG by brain MRI showing tumor in pons occupying >50% of pons volume with brainstem enlargement
- Karnofsky Performance Status score of 60 or higher
- Expected survival time of at least 3 months
You will not qualify if you...
- Presence of extracranial metastases
- Presence of spinal cord tumors or leptomeningeal disease dissemination
- Active hemorrhage detected on cranial MRI prior to enrollment
- Inability to undergo cranial MRI scanning due to contraindications or incompatible implants
- Prior treatment with oncolytic virus therapy or other gene therapy agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - About 2 years
Participants receive VRT106 combined with radiotherapy to treat diffuse midline glioma or diffuse intrinsic pontine glioma.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Y
Yuanyuan Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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