Evaluating VG2025 for patients with advanced solid tumors

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

This study is testing a new injection called VG2025 to see if it can be safely used to help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Virogin Biotech Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05477849 on ClinicalTrials.gov

What this trial studies

This Phase 1 open-label clinical trial aims to assess the safety, tolerability, and pharmacokinetics of VG2025, a recombinant human IL12/15 dual-regulated oncolytic HSV-1 injection, in patients with advanced malignant solid tumors that have not responded to standard treatments. The study will utilize a dose-escalation design to identify the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Participants will be monitored for dose-limiting toxicities over a 4-week evaluation period following the initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced malignant solid tumors who have failed standard treatment options.

Not a fit: Patients with active herpes simplex virus infections or those who have received other investigational drugs within 4 weeks prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are resistant to conventional therapies.

How similar studies have performed: While this approach is novel, similar studies using oncolytic viruses have shown promising results in treating solid tumors.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Tingbo Liang, M.D.，PhD — Zhejiang University
• Study coordinator: Yinan Shen

Conditions Advanced Malignant Solid Tumor