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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wangshuhang@cicams.ac.cn
• Phone: 13581809307

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.