Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
Conditions
Keywords
Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Intrinsic Pontine Glioma
Brief summary
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).
Interventions
DRUGVRT106 for injection
VRT106, iv
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | 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. |
| Overall survival | About 2 years | Time from initial administration to death. |
Countries
China
Contacts
CONTACTYuanyuan Chen
STUDY_CHAIRYuanyuan Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed