A Phase 1 Study to Test the Safety and Effects of IDOV-Immune, an Oncolytic Virus Treatment, for Adults with Advanced Solid Tumors Not Responding to Standard Therapies

What this Trial Is About

Researchers are evaluating an investigational treatment called IDOV-Immune, a genetically engineered oncolytic vaccinia virus, in adults with advanced solid tumors that have not responded to standard treatments. This Phase I, first-in-human clinical trial aims to determine the safety, tolerability, and highest safe dose of IDOV-Immune while studying how the virus behaves in the body and its effects on the immune system and tumors. The study addresses the unmet need for new therapies in patients with advanced cancers who have limited options. Participants receive a single intravenous infusion of IDOV-Immune on Day 1 of a 28-day treatment cycle. The study uses a dose-escalation design guided by observed side effects to identify the recommended dose for future studies. After dose escalation, expansion groups may be enrolled to further assess safety and preliminary antitumor activity. The trial takes place at multiple sites in the United States and Australia. During the study, participants undergo frequent safety assessments including physical exams, laboratory tests, imaging scans, and immune response monitoring. Researchers also evaluate how the virus moves through and affects the body, tumor responses, and immune biomarkers. The primary outcomes focus on dose-limiting toxicities and safety over 28 days, with follow-up for up to two years. Secondary outcomes include tumor response rates, progression-free survival, and antibody responses up to 12 months. Overall participation may last up to two years depending on follow-up.

IDOV-Immune for Advanced Solid Tumors