To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
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.
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).
Single group
VRT106 for injection
DrugVRT106, iv
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.
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.
Overall survival
Time from initial administration to death.
Click on the lead sponsor to view all of their trials.
