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
1 other identifier
interventional
42
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2025
Longer than P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
September 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
January 2, 2026
July 1, 2025
3.3 years
July 15, 2025
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
About 2 years
Secondary Outcomes (4)
Overall survival
About 2 years
Objective response rate
About 2 years
Distribution and shedding of VRT106 virus
About 2 years
Overall survival rate
About 2 years
Study Arms (1)
VRT106
EXPERIMENTALVRT106 will be administered intravenously
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Tangdu Hospital of Air Force Medical University of the PLA
Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chengcheng Guo
Sun Yat-Sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 30, 2025
Study Start
September 2, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
June 30, 2029
Last Updated
January 2, 2026
Record last verified: 2025-07