Phase I Study of Safety and Effects of GC001 Oncolytic Virus Injection in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, viral distribution, shedding patterns, pharmacodynamics, immunogenicity, and initial antitumor effects of the GC001 oncolytic vaccinia virus injection in patients with advanced solid tumors. The study aims to identify dose-limiting toxicities, maximum tolerated dose, or maximum administered dose of the treatment in this population. This trial includes patients with various advanced solid tumors for which standard treatments are ineffective or unavailable. The study involves a dose escalation design with up to six dose groups ranging from 3 x 106 to 1 x 109 plaque-forming units PFU. Each participant receives a single intratumoral injection of GC001, up to 4 mL based on lesion size, targeting up to two measurable extracranial lesions. A Safety Monitoring Committee oversees dose escalation decisions based on safety, tolerability, and preliminary efficacy data. The study carefully monitors viral biodistribution, shedding, pharmacodynamics, and immune responses alongside antitumor activity. Participants will be observed closely for 28 days post-injection to assess safety and dose-limiting toxicities. Follow-up includes evaluations of tumor response, duration of response, and progression-free survival for up to two years. Assessments include imaging scans, viral monitoring, and immunologic tests. The study also includes ongoing safety monitoring, with adjustments to dosing, administration schedules, and biospecimen collection times as needed. Total participation duration varies based on individual follow-up requirements.

A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Advanced Solid Tumors