NCT07589257 A Study of VRT106 in Combination With Radiotherapy in Adult Patients With Diffuse Midline Glioma / Diffuse Intrinsic Pontine Glioma
| NCT ID | NCT07589257 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangzhou Virotech Pharmaceutical Co., Ltd. |
| Condition | Diffuse Midline Glioma, H3 K27M-Mutant |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2026-05-07 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To Evaluate the Preliminary Efficacy and Safety/Tolerability of VRT106 Combined with Radiotherapy in Adult Patients with DMG/DIPG
Eligibility Criteria
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.
Contact & Investigator
Yuanyuan Chen
STUDY CHAIR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT07589257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Diffuse Midline Glioma, H3 K27M-Mutant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07589257 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07589257 currently recruiting?
Yes, NCT07589257 is actively recruiting participants. Contact the research team at chenyy2@sysucc.org.cn for enrollment information.
Where is the NCT07589257 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07589257 clinical trial?
NCT07589257 is sponsored by Guangzhou Virotech Pharmaceutical Co., Ltd.. The principal investigator is Yuanyuan Chen at Sun Yat-Sen University Cancer Center. The trial plans to enroll 10 participants.