Phase I Study of GO306 Oncolytic Vaccinia Virus Injection to Assess Safety and Early Effectiveness in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are studying the safety, tolerability, and preliminary effectiveness of GO306 Recombinant Oncolytic Vaccinia Virus Injection in patients with advanced solid tumors who have not responded to standard treatments. This open-label, non-randomized trial uses a dose-escalation design to explore the best dose and safety profile. The trial has two parts first to find the maximum tolerated dose and then to evaluate repeated doses in specific tumor types. The study involves two phases Part 1 uses a 33 design with single intratumoral or intracavitary injections of GO306 at low, medium, and high doses to determine the recommended dose for further study. Part 2 involves multiple doses of GO306 given weekly or every two weeks at the recommended dose to evaluate safety and explore preliminary effectiveness in selected tumor types. Participants will receive treatment injections and undergo monitoring for side effects, pharmacokinetics, viral shedding, and immune response. Researchers will assess adverse events, dose-limiting toxicities, and treatment responses using imaging. Follow-up evaluations include laboratory tests and immunological assessments. Study participation may last months, with some outcomes monitored up to five years after treatment.

A Clinical Study of GO306 in Patients With Advanced Solid Tumors