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Colorectal CancerGeneticsFirst-in-humanBiologicalPhase 1

What this study is

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.

What's being tested

  • IDOV-Immune (oncolytic vaccinia virus)

    Intervention · BIOLOGICAL

    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).

Study details

Official title
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.
Conditions
Colorectal Cancer · Pancreatic Cancer · Melanoma · Ovarian Cancer · Gastric Cancer · Esophageal Cancer · Hepatocellular Carcinoma · Renal Cell Carcinoma · Breast Cancer · Sarcoma · Bladder Cancer · Lung Cancer · Prostate Cancer · Cervical Cancers · Head and Neck Cancers · Adrenal Gland Tumors
Enrolling
78 people
Starts
2025-08-25
Est. completion
2027-05-31
Design
Open-label, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗