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

NCT ID: NCT07093814

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VRT106

VRT106 will be administered intravenously

Group Type EXPERIMENTAL

VRT106

Intervention Type DRUG

VRT106,intravenous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VRT106

VRT106,intravenous

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guangzhou Virotech Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chengcheng Guo

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Site Status NOT_YET_RECRUITING

Sanbo Brain Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

The Cancer Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China

Site Status NOT_YET_RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Tangdu Hospital of Air Force Medical University of the PLA

Xi’an, Shanxi, China

Site Status NOT_YET_RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chengcheng Guo

Role: CONTACT

020-87343990

Ke Sai

Role: CONTACT

020-87343890

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

0551-62282931

Role: primary

010-62856766

Role: primary

023-65075696

Role: primary

020-62787238

Role: primary

020-87343990

Role: primary

0755-83464301

Role: primary

0756-2528895

Role: primary

0771-5323064

Role: primary

0531-82165413

Role: primary

029-84717761

Role: primary

021-87315215

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VRT106-CN02(INVIGOR-101)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Study of Oncolytic Virus in Glioblastoma
NCT07145047 RECRUITING PHASE1/PHASE2
A Clinical Trial of P134 Cells in Recurrent Glioblastoma
NCT07318818 NOT_YET_RECRUITING PHASE1/PHASE2