VG2062, an oncolytic HSV-1 therapy for people with advanced solid tumors.

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.

This trial will try VG2062, a genetically engineered herpes virus designed to stimulate anti-tumor immunity, in adults with advanced solid tumors that no longer respond to standard 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 (Hebei)
• Trial ID: NCT07262164 on ClinicalTrials.gov

What this trial studies

This is an open-label Phase 1, dose-escalation trial using a standard 3+3 design in HSV-seropositive adults with advanced malignant solid tumors. Participants receive intratumoral VG2062 and are monitored for safety, tolerability, pharmacokinetics, and biological effects. The trial will escalate through multiple dosing cohorts to determine dose-limiting toxicities, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RP2D). The dose-limiting toxicity evaluation period is Day 1 through Day 28 after treatment initiation.

Who should consider this trial

Good fit: Adults aged 18 to 75 who are HSV-seropositive with advanced malignant solid tumors refractory to standard therapies, who can provide informed consent and follow contraception requirements if of childbearing potential, are the intended participants.

Not a fit: Patients with active herpes simplex recurrence or clinical HSV infection, recent major surgery or significant trauma within 4 weeks, or recent participation in other investigational drug trials are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, VG2062 could offer a new immune-stimulating local therapy that helps shrink tumors and control disease in patients whose cancers no longer respond to standard treatments.

How similar studies have performed: Oncolytic HSV therapies such as T-VEC have shown clinical benefit in certain cancers, but VG2062's dual IL-12/IL-15 regulation is a newer design with limited prior human data.

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

Hebei

• No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province — Hebei, China (Recruiting)

Study contacts

• Principal investigator: Ning Li, M.D.，PhD — No. 67, Huayuan Road, Langfang Economic and Technological Development Zone, Hebei Province
• Study coordinator: Shu hang Wang

Conditions Advanced Malignant Solid Tumor