A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

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.

This study is an open-label, single-arm Phase I/II clinical trial comprising two parts: Phase I and Phase II. Phase I is a dose-escalation phase, with the primary objective of assessing the safety and tolerability of VRT106 at escalating doses in subjects with recurrent/progressive glioblastoma and confirming the Recommended Phase II Dose (RP2D). Phase II is a dose-expansion phase, in which subjects will receive VRT106 at the RP2D dose level, aiming to further evaluate the efficacy and safety of VRT106 in subjects with recurrent/progressive glioblastoma.

Inclusion Criteria:

• 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.
• An expected survival time of≥3 months.
• Have sufficient organ function.
• Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first use of the study drug (if a false-positive pregnancy test result is due to non-pregnancy factors such as illness, further testing via ultrasound or other methods is required, and the investigator must confirm the absence of pregnancy before enrollment).
• Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.

Exclusion Criteria:

• 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.
• Patients who can't have a cranial MRI scan.
• Women who are breastfeeding.