NCT07682870 A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of VG2025 Intravenous Injection in Subjects With Advanced Solid Tumors
| NCT ID | NCT07682870 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Virogin Biotech Ltd. |
| Condition | Advanced Malignant Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-09-04 |
| Primary Completion | 2028-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2026-09-04 with a primary completion date of 2028-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 75 years (inclusive); Open to all genders. 2. 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. 3. Participants must test positive for Herpes Simplex Virus Type 1 (HSV-1) antibodies (HSV-1 IgG or HSV-1 IgM). 4. 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. Exclusion Criteria: 1. 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. 2. Participants who have received anticancer therapy or radiation therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to enrollment. 3. Underwent major surgery (excluding needle biopsy or intravenous catheterization) or interventional/ablation therapy within 4 weeks prior to the first dose. 4. Individuals with addiction to alcohol, drugs, or other substances; participants who have been abstinent for more than 2 years are eligible for en. 5. 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. 6. Any other circumstances that, in the investigator's judgment, render the participant unsuitable for participation in the clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07682870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Malignant Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07682870 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07682870 currently recruiting?
Yes, NCT07682870 is actively recruiting participants. Contact the research team at jjb11501@rjh.com.cn for enrollment information.
Where is the NCT07682870 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07682870 clinical trial?
NCT07682870 is sponsored by Virogin Biotech Ltd.. The trial plans to enroll 42 participants.