Glioblastoma
Conditions
Keywords
Glioblastoma
Brief summary
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.
Detailed description
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.
Interventions
DRUGVRT106
VRT106,intravenous
Sponsors
Guangzhou Virotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma | About 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | About 2 years | Time from initial administration to death |
| Objective response rate | About 2 years | Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR) |
| Distribution and shedding of VRT106 virus | About 2 years | Concentration of VRT106 virus in blood |
| Overall survival rate | About 2 years | Overall survival rates at 6, 9 and 12 months |
Countries
China
Contacts
Primary ContactChengcheng Guo
Backup ContactKe Sai
Outcome results
None listed