Phase 1 Study of VG2062 Injection for Safety and Dose Testing in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating VG2062, a recombinant human IL1215 dual-regulated oncolytic HSV-1 injection, in people with advanced malignant solid tumors that have not responded to standard treatments. This Phase I, open-label study focuses on participants who have been previously exposed to herpes simplex virus HSV. The trial aims to determine the safety, tolerability, and recommended dose of VG2062 for future Phase II studies. The study uses a standard 33 dose-escalation design with multiple dosing groups, where small cohorts of participants receive increasing doses of VG2062 to monitor safety and identify the maximum tolerated dose MTD and recommended Phase II dose RP2D. The dose limiting toxicity DLT period lasts 28 days from the first treatment. Up to 30 HSV-seropositive participants will be enrolled in this single-arm trial. Participants will be closely monitored for adverse events and serious adverse events over 12 months, with key safety evaluations during the first 28 days. Researchers will also assess pharmacokinetics, biological effects, tumor response rates, duration of response, disease control, progression-free survival, overall survival, and antibody levels. The total participation includes treatment, follow-up, and safety assessments lasting up to one year.

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2062 in Patients With Solid Tumors