Advanced Malignant Solid TumorPhase 1NCT07262164
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 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
VG2062 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
- 18 Mar 2026to Aug 2028
- 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
No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
Hebei
Ning Li, +86 01087788165, lining@cicams.ac.cn
About this study
Official title: An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors.
VG2062 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 VG2062, and recommended dose of VG2062 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
- 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.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on.
Measured: 12 months
MTD/RP2D
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
Measured: During the 28 day DLT observation period
Secondary outcomes (7)
Level of deoxyribonucleic acid (DNA)
Shedding profile of detectable VG2062 deoxyribonucleic acid (DNA)
Measured: 12 months
ORR
Objective response rate (ORR)
Measured: 12 months
DoR
Duration of relief（DoR）
Measured: 12 months
DCR
Disease control rate (DCR)
Measured: 12 months
PFS
Progression-free survival (PFS)
Measured: 12 months
OS
Overall Survival (OS)
Measured: 12 months
Antibodies
VG2062 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 posted3 Dec 2025
- Study start18 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionAug 2028 (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
- Ning Li, M.D.，PhD, Principal investigator, No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262164
- Sponsor's protocol ID
- VG203-C101
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Biological Effects of VG2062 in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07262164
- Acronym / sponsor ID
- VG203-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
- 18 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Dec 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.
VG2062 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 VG2062, and recommended dose of VG2062 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 Injection1. 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
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 months
The assessment is conducted by monitoring the severity of AEs and SAEs during the study, including performing protocol-specified vital signs checks, physical examinations, 12-lead ECGs, laboratory tests, DLTs, and so on.
MTD/RP2D
Time frame: During the 28 day DLT observation period
Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)
7 secondary outcomes
Level of deoxyribonucleic acid (DNA)
Time frame: 12 months
ORR
Time frame: 12 months
DoR
Time frame: 12 months
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 25 Mar 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.
Ning Li, M.D.，PhD principal investigator
No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
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 25 Mar 2026. 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 Shu hang Wang (13581809307, wangshuhang@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 12 months). 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 25 Mar 2026.