Actively Recruiting
Phase 1 Study of VG2025 Injection to Assess Safety and Dose in Adults with Advanced Malignant Solid Tumors
Led by Shanghai Virogin Biotech Co., Ltd. · Updated on 2025-04-01
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating VG2025, a recombinant human IL1215 dual-regulated oncolytic HSV-1 injection, in adults with advanced malignant solid tumors that have not responded to standard treatments. This open-label Phase I trial aims to determine the safety, tolerability, and recommended dose of VG2025 for future studies. The trial is conducted in patients who are positive for herpes simplex virus HSV and refractory to conventional therapies. The study uses a standard 33 dose-escalation design with multiple dosing cohorts, treating up to 30 HSV-seropositive participants. Each cohort involves three patients receiving escalating doses of VG2025, with careful monitoring for dose-limiting toxicities during the first 28 days of treatment. This design helps establish the maximum tolerated dose and the recommended dose for Phase II trials. Participants will be closely monitored for safety and biological effects over 12 months, including adverse events, serious adverse events, DNA levels, interleukin levels, tumor response rates, disease control rates, progression-free survival, overall survival, and antibody responses. The trial includes frequent assessments during the dose-limiting toxicity period and long-term follow-up to evaluate both treatment impact and safety.
CONDITIONS
Brief Title
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients with Solid Tumors
Research Team
Y
Yinan Shen
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