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RecruitingNCT07589257Updated May 15, 2026

A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma

A Phase 2 interventional study of VRT106 for injection in Diffuse Midline Glioma, H3 K27M-Mutant and Diffuse Intrinsic Pontine Glioma, sponsored by Guangzhou Virotech Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Guangzhou Virotech Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Diffuse Intrinsic Pontine Glioma

Keywords

  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Diffuse Intrinsic Pontine Glioma
03

In context

Diffuse Intrinsic Pontine Glioma

118 studies on the registry are indexed under Diffuse Intrinsic Pontine Glioma; 40 are open to participants now.

This study's planned enrollment of 10 is below the median of 30 across 107 interventional studies indexed under Diffuse Intrinsic Pontine Glioma.

Browse Diffuse Intrinsic Pontine Glioma studies →

Lead sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    VRT106

    VRT106

    Drug: VRT106 for injection

Interventions

  • DrugVRT106 for injection

    VRT106, iv

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: About 2 years

Secondary outcomes

  1. 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.

    Time frame: About 2 years

  2. Overall survival

    Time from initial administration to death.

    Time frame: About 2 years

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07589257
Lead sponsor
Guangzhou Virotech Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 15, 2026
Start date
May 7, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 15, 2026

Study contacts

Yuanyuan Chen
Contact
chenyy2@sysucc.org.cn
202-87343543
Yuanyuan Chen
study chair · Sun Yat-Sen University Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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