A first-in-human, phase 1, multi-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary evidence of antitumor activity of IDOV-Immune in adult participants with advanced solid tumors (NCT06910657)

This is a Phase I clinical trial evaluating an investigational treatment called IDOVImmune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor. The purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors. Participants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer. This study is being conducted at multiple sites in the United States and Australia.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Malaka Ameratunga

Key inclusion data

Age = 18 years and above; Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exist; At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures); Ability to provide informed consent and comply with study requirements.