VRT106 injections for recurrent or progressive glioblastoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• The Second Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of USTC
  Hefei, Anhui, China Not yet recruiting

Study contacts

• Principal investigator: Chengcheng Guo — Sun Yat-Sen University Cancer Center
• Study coordinator: Chengcheng Guo
• Email: guochch@sysucc.org.cn
• Phone: 020-87343990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.