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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou Virotech Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • VRT106 for injection

Treatment groups

10 Participants
are divided into 1 treatment group