Actively Recruiting
A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
Led by Guangzhou Virotech Pharmaceutical Co., Ltd. · Updated on 2026-01-02
42
Participants Needed
11
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of VRT106 in adults with recurrent or progressive glioblastoma. This open-label, single-arm Phase I/II clinical trial includes patients aged 18 to 70 years. The study aims to find the best dose of VRT106 and further assess its impact on this brain cancer condition. The trial has two parts: Phase I involves gradually increasing doses of VRT106 given intravenously to find a safe and tolerable dose. Phase II uses this recommended dose to further study VRT106's effects and safety in participants. Treatment is given through intravenous infusion, and the study carefully monitors patients throughout these phases. Participants will undergo regular assessments including safety evaluations, monitoring of overall survival, response to treatment, and tracking of the VRT106 virus in the body. The study lasts about two years, during which researchers will collect data to understand how participants respond to the treatment and ensure close safety monitoring.
CONDITIONS
Brief Title
A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years at the time of signing informed consent
- Diagnosed with recurrent or progressive glioblastoma
- Karnofsky Performance Status score of 60 or higher within 28 days before first VRT106 dose
- Expected survival time of at least 3 months
- Sufficient organ function
- Female patients of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Participants of childbearing potential agree to use effective birth control from consent to 90 days after last dose
- Able and willing to follow and complete all trial procedures with informed consent
You will not qualify if you...
- Presence of extracranial metastases
- Previous treatment with oncolytic viruses or gene therapy
- Treatment with other unlisted investigational drugs or devices within 4 weeks prior to first VRT106 dose
- Known allergy to any component of VRT106
- Inability to undergo cranial MRI scan
- Women who are breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 2 years
Participants receive intravenous VRT106 to evaluate safety, tolerability, and preliminary efficacy in recurrent/progressive glioblastoma.
Regular visits for dosing and assessments during treatment
Trial Site Locations
Total: 11 locations
1
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Not Yet Recruiting
2
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
5
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
6
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
7
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Actively Recruiting
8
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
9
Qilu Hospital of Shandong University
Jinan, Shandong, China
Not Yet Recruiting
10
Tangdu Hospital of Air Force Medical University of the PLA
Xi’an, Shanxi, China
Not Yet Recruiting
11
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
C
Chengcheng Guo
K
Ke Sai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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