RecruitingRecruiting
A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
NCT07093814 · Guangzhou Virotech Pharmaceutical Co., Ltd.
In plain English
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Official title
A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 42 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-02
Estimated completion: 2029-06-30
Last updated: 2026-01-02
Interventions
Drug: VRT106
Primary outcomes
- • Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma (About 2 years)
Sponsor
Guangzhou Virotech Pharmaceutical Co., Ltd. · industry
Contacts & investigators
ContactChengcheng Guo · contact · guochch@sysucc.org.cn · 020-87343990
ContactKe Sai · contact · saike@sysucc.org.cn · 020-87343890
InvestigatorChengcheng Guo · principal_investigator, Sun Yat-Sen University Cancer Center
All locations (11)
The First Affiliated Hospital of USTCNot Yet Recruiting
Hefei, Anhui, China
Sanbo Brain Hospital Capital Medical UniversityNot Yet Recruiting
Beijing, Beijing Municipality, China
The Cancer Hospital Affiliated to Chongqing UniversityNot Yet Recruiting
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical UniversityNot Yet Recruiting
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer CenterRecruiting
Guangzhou, Guangdong, China
Shenzhen Second People's HospitalRecruiting
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Zhuhai, Guangdong, China
Guangxi Medical University Cancer HospitalRecruiting
Nanning, Guangxi, China
Qilu Hospital of Shandong UniversityNot Yet Recruiting
Jinan, Shandong, China
Tangdu Hospital of Air Force Medical University of the PLANot Yet Recruiting
Xi’an, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China