RecruitingPhase 1NCT06910657

IDOV-Immune for Advanced Solid Tumors

A First-in-human, Phase I, 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


Sponsor

ViroMissile, Inc.

Enrollment

78 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental treatment called IDOV-Immune, a type of modified virus (oncolytic virus) that is designed to enter and destroy cancer cells, in people with advanced solid tumors that have stopped responding to standard therapies. **You may be eligible if...** - You are 18 or older - You have an advanced solid tumor confirmed by biopsy that has progressed despite standard treatment, or for which no standard treatment exists - You are in good overall health (ECOG 0–1) - Your tumor is measurable on imaging - Your organ function and bone marrow are adequate - At least 28 days have passed since major surgery, prior immunotherapy, or radiation **You may NOT be eligible if...** - You have received a prior oncolytic virus treatment - You have had a recent smallpox or monkeypox vaccination or active vaccinia virus infection - You are pregnant or not using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIDOV-Immune (oncolytic vaccinia virus)

IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system. This study investigates IDOV-Immune as a single intravenous infusion in a first-in-human, Phase 1, dose-escalation trial in participants with advanced solid tumors. The dose will escalate based on safety data, with a goal of identifying the recommended Phase 2 dose (RP2D).


Locations(6)

Washington University School of Medicine

St Louis, Missouri, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT06910657


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