GlioblastomaPhase 1/2NCT07093814
A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
A Phase 1/2 study testing VRT106 in people with Glioblastoma, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- VRT106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 11 sitesChina
- Study dates
- 2 Sep 2025to 30 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality
010-62856766, myzhou1001@126.com
Junping Zhang, Professor
- Not yet recruiting
The Cancer Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality
023-65075696, czll6545@126.com
Haifeng Yang, Professor
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
020-62787238, nfyyec@163.com
Songtao Qi, Professor
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
020-87343990, llwyh@sysucc.org.cn
Chengcheng Guo, Professor
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
021-87315215
Chun Wang, Professor
- Not yet recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui
0551-62282931, ahslyyllwyh@163.com
Chaoshi Niu, Professor
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
0531-82165413, qlyygcp_ec@qiluhospital.com
Gang Li, Professor
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
0771-5323064
Ligen Mo, Professor
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
0755-83464301, lunli707@126.com
Fanfan Chen, Professor
- Not yet recruiting
Tangdu Hospital of Air Force Medical University of the PLA
Xi’an, Shanxi
029-84717761, tangduec@126.com
Liang Wang, Professor
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong
0756-2528895, zdwyllwyh@163.com
Rui You, Professor
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
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.
Read the detailed description
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
- Glioblastoma
- Being tested
- VRT106
- Keywords
- Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT106Drug
VRT106,intravenous
| Study group | Role | What they receive |
|---|---|---|
| VRT106 | Experimental | VRT106 will be administered intravenously Receives: Drug: VRT106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
To evaluate the safety and tolerability of VRT106 in patients with recurrent/progressive glioblastoma and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.
Measured: About 2 years
Secondary outcomes (4)
Overall survival
Time from initial administration to death
Measured: About 2 years
Objective response rate
Objective response rate assessed according to the Neuro-Oncology Response Evaluation Criteria, complete response (CR) + partial response (PR)
Measured: About 2 years
Distribution and shedding of VRT106 virus
Concentration of VRT106 virus in blood
Measured: About 2 years
Overall survival rate
Overall survival rates at 6, 9 and 12 months
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start2 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chengcheng Guo, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093814
- Sponsor's protocol ID
- VRT106-CN02（INVIGOR-101）
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma
- ClinicalTrials.gov ID
- NCT07093814
- Acronym / sponsor ID
- VRT106-CN02（INVIGOR-101）
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRT106 | Experimental | Drug: VRT106VRT106 will be administered intravenously |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRT106VRT106,intravenous | Drug | VRT106 |
Primary outcome
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma
Time frame: About 2 years
To evaluate the safety and tolerability of VRT106 in patients with recurrent/progressive glioblastoma and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose(RP2D), which will provide a recommended dose for subsequent clinical trials. The specific outcome indicator data that need to be evaluated and collected include: adverse event, physical examinations, vital signs, clinical laboratory tests (including blood routine, blood biochemistry.urine routine, coagulation function), Eastern Cooperative Oncology Group (ECOG) performance status, twelve-lead electrocardiogram(ECG) and concomitant medication assessments.
4 secondary outcomes
Overall survival
Time frame: About 2 years
Objective response rate
Time frame: About 2 years
Distribution and shedding of VRT106 virus
Time frame: About 2 years
Overall survival rate
Time frame: About 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengcheng Guo principal investigator
Sun Yat-Sen University Cancer Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VRT106 in people with Glioblastoma, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengcheng Guo (020-87343990, guochch@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.