Phase I Study of Intratumoral Injection of Oncolytic Vaccinia Virus GC001 for Safety and Antitumor Activity in Adults With Recurrent or Progressive High-Grade Gliomas

What this Trial Is About

Researchers are evaluating the safety, tolerability, distribution, shedding, immune response, and initial antitumor effects of an investigational oncolytic vaccinia virus called GC001 in patients with recurrent or progressive high-grade gliomas. This Phase I open-label study includes dose-escalation and dose-expansion phases to determine the best dose and assess early signs of effectiveness in patients whose tumors have returned or worsened after standard treatments. The trial involves seven dose groups ranging from 1x106 to 1x109 PFU of GC001 delivered by intratumoral injection using Ommaya capsules. Dose escalation follows a 33 design with an accelerated titration for the lowest doses and traditional escalation for higher doses. Following the dose-escalation phase, the recommended dose may be used to enroll additional patients in the dose-expansion phase to further evaluate safety and preliminary antitumor activity. Participants will be closely monitored for up to 28 days after injection for dose-limiting toxicities and safety. Researchers will assess tumor response using established neuro-oncology criteria over a follow-up period up to two years. Other evaluations include pharmacodynamics, immunogenicity, virus shedding, and biodistribution. Patients will undergo surgical procedures for capsule placement and have regular clinical and laboratory assessments throughout the study.

A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas