RecruitingPhase 1Phase 2NCT07093814

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


Sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Enrollment

42 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria8

  • 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 Criteria6

  • 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.

Interventions

DRUGVRT106

VRT106,intravenous


Locations(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

View Full Details on ClinicalTrials.gov

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NCT07093814


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