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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (11)
Facility
City
Region
Status
The First Affiliated Hospital of USTC
Hefei
Anhui
Not Yet Recruiting
Sanbo Brain Hospital Capital Medical University
Beijing
Beijing Municipality
Not Yet Recruiting
The Cancer Hospital Affiliated to Chongqing University
Chongqing
Chongqing Municipality
Not Yet Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Guangdong
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Shenzhen Second People's Hospital
Shenzhen
Guangdong
Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai
Guangdong
Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Recruiting
Qilu Hospital of Shandong University
Jinan
Shandong
Not Yet Recruiting
Tangdu Hospital of Air Force Medical University of the PLA
Xi’an
Shanxi
Not Yet Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Guangzhou Virotech Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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