This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent/progressive glioblastoma.
Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
Males and females are aged at 18-70 years (including borderline values) at the time of signing the ICF, male or female.
Diagnosed with recurrent/progressive glioblastoma.
Karnofsky Performance Status (KPS) score ≥60 within 28 days prior to the first administration of the study drug.
Patients with extracranial metastases.
Previously received treatment with oncolytic viruses, gene therapy.
Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of VRT106.
Subject is known to have an allergic reaction to any of the components of VRT106.
Single group
VRT106
DrugVRT106,intravenous
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
To evaluate the safety and tolerability of VRT106 in patients with recurrent/progressive glioblastoma and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.
Overall survival
Time from initial administration to death
Objective response rate
Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR)
Distribution and shedding of VRT106 virus
Concentration of VRT106 virus in blood
Overall survival rate
Overall survival rates at 6, 9 and 12 months
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