NCT05477849 A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
| NCT ID | NCT05477849 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Virogin Biotech Co., Ltd. |
| Condition | Advanced Malignant Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-08-23 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 30 participants in total. It began in 2022-08-23 with a primary completion date of 2025-10-31.
⚠ 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. Signed written informed consent form. 2. Age 18 to 75 years (inclusive), male or female. 3. Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage. 4. 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. Exclusion Criteria: 1. Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug. 2. Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug. 3. 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. 4. Other active uncontrolled infection. 5. Known alcohol or drug dependence. 6. Subjects with mental disorders or poor compliance. 7. Women who are pregnant or breastfeeding. 8. Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
Contact & Investigator
Tingbo Liang, M.D.，PhD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT05477849 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 NCT05477849 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 NCT05477849 currently recruiting?
Yes, NCT05477849 is actively recruiting participants. Contact the research team at fysyn@163.com for enrollment information.
Where is the NCT05477849 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05477849 clinical trial?
NCT05477849 is sponsored by Shanghai Virogin Biotech Co., Ltd.. The principal investigator is Tingbo Liang, M.D.，PhD at Zhejiang University. The trial plans to enroll 30 participants.