Advanced Malignant Solid TumorPhase 1/2NCT07682870
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors
A Phase 1/2 study testing Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection in people with Advanced Malignant Solid Tumor, run by Virogin Biotech 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
- 42 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2026to 3 Sep 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years (inclusive); Open to all genders.
- Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and/or cytology, or for whom no standard therapy is currently approved.
- Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
- Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.
Who cannot join
- Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.
- Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
- Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
- Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
- Any other serious underlying medical conditions, or mental or psychological disorders, hereditary diseases, etc., that, in the investigator's judgment, may interfere with disease staging, treatment, or follow-up; affect the participant's compliance; or place the participant at high risk.
- Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.
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
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Bai yong Shen, 021-64370045, shenby@shsmu.edu.cn
About this study
Official title: An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced 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.
- 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
- Dose level 6
- Dose level 7
| 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 42 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.
Safety：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 (8)
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: 12 months
Duration of relief（DOR）
Duration of relief（DOR）
Measured: 12 months
DCR
Disease control rate (DCR)
Measured: 12 months
PFS
Progression-free survival (PFS)
Measured: 12 months
Immunogenicity Parameters
Incidence of antibodies against VG2025, anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Measured: 12 months
Efficacy and Safety of VG2025 and Its Correlation with CEA Levels
A preliminary analysis of the correlation between the efficacy and safety of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels.
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 posted6 Jul 2026
- Study start4 Sep 2026 (estimated)
- Primary completion2 Dec 2028 (estimated)
- Study completion3 Sep 2029 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virogin Biotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682870
- Sponsor's protocol ID
- VG201-IV-C101
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I/IIa Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of VG2025 Intravenous Treatment in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07682870
- Acronym / sponsor ID
- VG201-IV-C101
- Conditions
- Advanced Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Virogin Biotech Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 2 Dec 2028 (estimated)
- Study completion
- 3 Sep 2029 (estimated)
- First posted
- 6 Jul 2026 (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.
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 42 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)
- Age 18 to 75 years (inclusive); Open to all genders.
- Phase I: Participants with advanced solid tumors who have failed standard therapy (due to intolerance or disease progression following treatment) as confirmed by histopathology and/or cytology, or for whom no standard therapy is currently approved.
- Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM).
- Within 7 days prior to the first administration of the study drug, female participants of childbearing potential must confirm a negative serum pregnancy test. Participants of childbearing potential and their partners must agree to use effective contraception during the study drug administration period and for 90 days after the last dose.
Key exclusion criteria (6 listed)
- Participants experiencing an active herpes simplex virus (HSV) recurrence with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, or genital herpes; or those requiring anti-HSV treatment.
- Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment.
- Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose.
- Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en.
- Any other serious underlying medical conditions, or mental or psychological disorders, hereditary diseases, etc., that, in the investigator's judgment, may interfere with disease staging, treatment, or follow-up; affect the participant's compliance; or place the participant at high risk.
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 6. Dose level 6 7. Dose level 7 | Drug | 3+3 design |
Primary outcome
Safety：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)
8 secondary outcomes
Level of deoxyribonucleic acid (DNA)
Time frame: 12 months
Interleukin level
Time frame: 12 months
ORR
Time frame: 12 months
Duration of relief（DOR）
Time frame: 12 months
DCR
Time frame: 12 months
PFS
Time frame: 12 months
Immunogenicity Parameters
Time frame: 12 months
Efficacy and Safety of VG2025 and Its Correlation with CEA Levels
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 22 Sep 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.
1 site 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 Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection in people with Advanced Malignant Solid Tumor, run by Virogin Biotech 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 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 22 Sep 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 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 Jia bin Jin (021-64370045, jjb11501@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety：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 22 Sep 2026.