Advanced Malignant Solid TumorPhase 1NCT05477849
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
A Phase 1 study testing Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection in people with Advanced Malignant Solid Tumor, run by Shanghai Virogin Biotech Co., Ltd. at 1 site in China.
Trial summary
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2022to 31 Dec 2025
- 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
- Signed written informed consent form.
- Age 18 to 75 years (inclusive), male or female.
- Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
- Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
Who cannot join
- Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
- Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
- In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
- Other active uncontrolled infection.
- Known alcohol or drug dependence.
- Subjects with mental disorders or poor compliance.
- Women who are pregnant or breastfeeding.
- Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Tingbo Liang, +86-0571-87236666, liangtingbo@zju.edu.cn
About this study
Official title: A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
Read the detailed description
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 InjectionDrug
Also called VG2025
- Dose level 1
- Dose level 2
- Dose level 3
- Dose level 4
- Dose level 5
| Study group | Role | What they receive |
|---|---|---|
| 3+3 design | Experimental | This is an open label, single-arm trial using standard 3+3 design, in up to 30 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients Receives: Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Measured: During the 28 day DLT observation period
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Measured: 12 months
Secondary outcomes (7)
Level of deoxyribonucleic acid (DNA)
Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)
Measured: 12 months
Interleukin level
Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels
Measured: 12 months
ORR
Objective response rate (ORR)
Measured: Multiple time points before and after administration
DCR
Disease control rate (DCR)
Measured: 12 months
PFS
Progression-free survival (PFS)
Measured: 12 months
OS
Overall Survival (OS)
Measured: 12 months
Antibodies
VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start23 Aug 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant 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
- Shanghai Virogin Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tingbo Liang, M.D.，PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477849
- Sponsor's protocol ID
- VG201-C101
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients with Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05477849
- Acronym / sponsor ID
- VG201-C101
- Conditions
- Advanced Malignant Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Virogin Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jul 2022 (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.
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
Detailed description
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3+3 design | Experimental | Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 InjectionThis is an open label, single-arm trial using standard 3+3 design, in up to 30 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed written informed consent form.
- Age 18 to 75 years (inclusive), male or female.
- Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage.
- Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
Key exclusion criteria (8 listed)
- Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug.
- Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug.
- In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on.
- Other active uncontrolled infection.
- Known alcohol or drug dependence.
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 |
|---|---|---|
| Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 InjectionAlso: VG20251. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5 | Drug | 3+3 design |
Primary outcome
MTD/RP2D
Time frame: During the 28 day DLT observation period
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 months
Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
7 secondary outcomes
Level of deoxyribonucleic acid (DNA)
Time frame: 12 months
Interleukin level
Time frame: 12 months
ORR
Time frame: Multiple time points before and after administration
DCR
Time frame: 12 months
PFS
Time frame: 12 months
OS
Time frame: 12 months
Antibodies
Time frame: 12 months
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 1 Apr 2025.
- 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.
Tingbo Liang, M.D.，PhD principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection in people with Advanced Malignant Solid Tumor, run by Shanghai Virogin Biotech Co., Ltd. at 1 site 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 4 inclusion and 8 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 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Yinan Shen (+86-0571-87236666, fysyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD/RP2D (time frame: During the 28 day DLT observation period). 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 1 Apr 2025.