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
ViroMissile, Inc.
78 participants
Aug 25, 2025
INTERVENTIONAL
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
Inclusion Criteria9
- Age ≥ 18 years.
- Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.
- ECOG performance status ≤ 1.
- Measurable disease per RECIST v1.1.
- Adequate organ and bone marrow function.
- At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).
- Negative pregnancy test for women of childbearing potential.
- Agreement to use effective contraception during treatment and for 3 months after.
- Ability to provide informed consent and comply with study requirements.
Exclusion Criteria13
- Prior treatment with an oncolytic virus.
- Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within 10 years.
- Active uncontrolled infection requiring systemic treatment.
- History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).
- Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).
- Active or symptomatic autoimmune disease requiring systemic therapy.
- Active or untreated CNS metastases (unless stable per protocol).
- Significant cardiac disease (e.g., NYHA Class III/IV heart failure).
- Interstitial lung disease or prior pneumonitis requiring steroids.
- Conditions requiring chronic immunosuppressive therapy.
- Severe skin disorders or history of pancreatitis.
- Bleeding disorders or history of recent serious thromboembolic events.
- Any medical or psychiatric condition that could interfere with study participation.
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06910657