Solid TumorPhase 1NCT06368921
A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors
A Phase 1 study testing VRT106 in people with Solid Tumor, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 3 sites in China.
Trial summary
To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- 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
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 19 Jun 2024to Dec 2027
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Have at least one injectable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
- An estimated survival time of ≥ 12 weeks.
Who cannot join
- Subject has received any anti-tumor treatment 4 weeks before using the IMP.
- Subject has received any prior oncolytic viruses or other gene therapies.
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Hongyun Zhao, zhaohy@syscc.org.cn
- Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong
Qi Dang
- Recruiting
Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan
Peng Zhang
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics, Biological Effects and Initial Efficacy of Recombinant Oncolytic Virus M1 for Injection (VRT106) in the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.
Read the detailed description
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.
- Conditions
- Solid Tumor
- Being tested
- VRT106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT106Biological
intratumoral injection
| Study group | Role | What they receive |
|---|---|---|
| VRT106 | Experimental | VRT106 Receives: Biological: 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 intratumoral injection of VRT106.
Incidence rate of TEAE
Measured: About 2 years
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Incidence rate of DLT
Measured: About 2 years
Secondary outcomes (4)
Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.
Measure the distribution and shedding of VRT106 following intratumoral injection using qPCR (quantitative polymerase chain reaction) method.
Measured: About 2 years
Assess the immunogenicity of intratumoral injection of VRT106.
Detect the presence of neutralizing antibodies against VRT106, which represent the potency of the neutralizing antibodies, using the PD50 value.
Measured: About 2 years
Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1.
Measured: About 2 years
Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1.
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 posted16 Apr 2024
- Study start19 Jun 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368921
- Sponsor's protocol ID
- VRT106-C01
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics, Biological Effects and Initial Efficacy of Recombinant Oncolytic Virus M1 for Injection (VRT106) in the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06368921
- Acronym / sponsor ID
- VRT106-C01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Apr 2024 (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.
To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.
Detailed description
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of IT injections of VRT106 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of VRT106 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of VRT106, and preliminarily exploring the anti-tumor effects of VRT106.
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 | Biological: VRT106VRT106 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at 18-75 years of age, inclusive, at the Screening Visit.
- Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Have at least one injectable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
Key exclusion criteria (4 listed)
- Subject has received any anti-tumor treatment 4 weeks before using the IMP.
- Subject has received any prior oncolytic viruses or other gene therapies.
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
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 |
|---|---|---|
| VRT106intratumoral injection | Biological | VRT106 |
Primary outcome
Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.
Time frame: About 2 years
Incidence rate of TEAE
Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Time frame: About 2 years
Incidence rate of DLT
4 secondary outcomes
Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.
Time frame: About 2 years
Assess the immunogenicity of intratumoral injection of VRT106.
Time frame: About 2 years
Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.
Time frame: About 2 years
Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.
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.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRT106 in people with Solid Tumor, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 3 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 6 inclusion and 4 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 3 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 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.
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 Hongyun Zhao (020-87343565, zhaohy@syscc.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 intratumoral injection of VRT106. (time frame: About 2 years). The study lists 2 primary outcomes in all. 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.