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

NCT07589257 | Recruiting Phase 2

• 1 other identifier: VRT106-CN06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG

Conditions

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

Keywords

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

Outcome Measures

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.

  About 2 years

Secondary Outcomes (2)

• Progression-Free Survival

  About 2 years

• Overall survival

  About 2 years

Study Arms (1)

VRT106

EXPERIMENTAL

VRT106

Drug: VRT106 for injection

Interventions

VRT106 for injection DRUG

VRT106, iv

VRT106

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Virotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Injections

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Yuanyuan Chen

  Sun Yat-Sen University Cancer Center

  STUDY CHAIR

Central Study Contacts

Yuanyuan Chen

CONTACT

202-87343543; chenyy2@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 15, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)