Phase I Trial of vvDD-hIL2-2-RG-1 Injection for Advanced Metastatic Gastrointestinal and Peritoneal Cancers

What this Trial Is About

This research study focuses on patients with advanced abdominal cancers, such as metastatic gastrointestinal tumors including esophageal, gastric, colon, rectal, liver, and pancreatic cancers. It aims to evaluate the safety and find the best dose of a new experimental drug called vvDD-hIL2, which is a genetically modified vaccinia virus designed to stimulate the immune system to target and destroy tumors while minimizing harm to healthy tissue. This Phase I trial is open-label and involves patients who have not responded to standard chemotherapy or immunotherapy. Participants will receive a single injection of vvDD-hIL2 directly into their abdominal tumors at one of three dose levels, escalating in cohorts of three patients each according to a standard dose-escalation design. After the first patient in each dose group is treated, there is a 28-day observation period to monitor for dose-limiting toxicities before enrolling additional patients or moving to a higher dose level. The treatment involves one needle injection per tumor, delivered intra-tumorally. Participants will be actively involved for up to two months, attending seven clinic visits and about four lab visits for evaluations. These visits include standard care procedures and study-specific tests such as blood draws, oral swabs, urinalysis, and tissue biopsies for tumor response and genomic analysis. The study team will monitor side effects closely, including pain, rash, fever, and fatigue, with particular attention to rare risks like rash transmission. Data and tissue samples may be used for future research.

Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors