VRT106 injections for recurrent or 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

This trial will test whether injections of VRT106 are safe and can help adults aged 18–70 with recurrent or progressive glioblastoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 11 sites (Hefei, Anhui and 10 other locations)
• Trial ID: NCT07093814 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase I/II trial with a Phase I dose-escalation portion followed by a Phase II dose-expansion portion. Phase I will escalate doses of VRT106 to determine safety, tolerability, and the recommended Phase II dose (RP2D). Phase II will treat additional patients at the RP2D to gather more data on efficacy and safety. Participants receive VRT106 injections and are monitored for tumor response, survival, and adverse events at participating centers in China.

Who should consider this trial

Good fit: Adults aged 18–70 with recurrent or progressive glioblastoma, a Karnofsky Performance Status ≥60, estimated survival of at least 3 months, and adequate organ function who can consent and comply with study procedures are ideal candidates.

Not a fit: Patients with poor performance status (KPS <60), life expectancy under 3 months, significant organ dysfunction, pregnancy, or those outside the 18–70 age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, VRT106 could provide a new treatment option that controls tumor growth or prolongs survival with an acceptable safety profile for patients with recurrent or progressive glioblastoma.

How similar studies have performed: Early-phase injectable or targeted approaches in recurrent glioblastoma have shown limited and variable results, so this approach remains experimental and unproven.

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.

Where this trial is running

Hefei, Anhui and 10 other locations

• The First Affiliated Hospital of USTC — Hefei, Anhui, China (Not_yet_recruiting)
• Sanbo Brain Hospital Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• The Cancer Hospital Affiliated to Chongqing University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
• Tangdu Hospital of Air Force Medical University of the PLA — Xi’an, Shanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Chengcheng Guo — Sun Yat-Sen University Cancer Center
• Study coordinator: Chengcheng Guo

Conditions Glioblastoma