Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
ID07093814

A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

Led by Guangzhou Virotech Pharmaceutical Co., Ltd. · Updated on 2026-01-02

42

Participants Needed

11

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of VRT106 in adults with recurrent or progressive glioblastoma. This open-label, single-arm Phase I/II clinical trial includes patients aged 18 to 70 years. The study aims to find the best dose of VRT106 and further assess its impact on this brain cancer condition. The trial has two parts: Phase I involves gradually increasing doses of VRT106 given intravenously to find a safe and tolerable dose. Phase II uses this recommended dose to further study VRT106's effects and safety in participants. Treatment is given through intravenous infusion, and the study carefully monitors patients throughout these phases. Participants will undergo regular assessments including safety evaluations, monitoring of overall survival, response to treatment, and tracking of the VRT106 virus in the body. The study lasts about two years, during which researchers will collect data to understand how participants respond to the treatment and ensure close safety monitoring.

CONDITIONS

Brief Title

A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years at the time of signing informed consent
  • Diagnosed with recurrent or progressive glioblastoma
  • Karnofsky Performance Status score of 60 or higher within 28 days before first VRT106 dose
  • Expected survival time of at least 3 months
  • Sufficient organ function
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before first dose
  • Participants of childbearing potential agree to use effective birth control from consent to 90 days after last dose
  • Able and willing to follow and complete all trial procedures with informed consent
Not Eligible

You will not qualify if you...

  • Presence of extracranial metastases
  • Previous treatment with oncolytic viruses or gene therapy
  • Treatment with other unlisted investigational drugs or devices within 4 weeks prior to first VRT106 dose
  • Known allergy to any component of VRT106
  • Inability to undergo cranial MRI scan
  • Women who are breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to about 2 years

Participants receive intravenous VRT106 to evaluate safety, tolerability, and preliminary efficacy in recurrent/progressive glioblastoma.

Regular visits for dosing and assessments during treatment

Trial Site Locations

Total: 11 locations

1

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Not Yet Recruiting

2

Sanbo Brain Hospital Capital Medical University

Beijing, Beijing Municipality, China

Not Yet Recruiting

3

The Cancer Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China

Not Yet Recruiting

4

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

5

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Actively Recruiting

6

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Actively Recruiting

7

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Actively Recruiting

8

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Actively Recruiting

9

Qilu Hospital of Shandong University

Jinan, Shandong, China

Not Yet Recruiting

10

Tangdu Hospital of Air Force Medical University of the PLA

Xi’an, Shanxi, China

Not Yet Recruiting

11

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

C

Chengcheng Guo

K

Ke Sai

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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