Tests IDOV-Immune, a virus therapy, in adults with advanced solid tumors
Tests a virus treatment that may attack cancer cells in adults with advanced tumors.
Key facts
- Who runs it
- ViroMissile, Inc.
- Where
- Houston, San Antonio, and St Louis, United StatesSee the 3 sitesAlso in 1 other country, 2 sites
- Trial code
- Registry title
- IDOV-Immune for Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 78 people, planned
- Started
- 25 Aug 2025
- Expected to end
- 31 May 2027
- Type of study
- Interventional
- Treatments tested
- IDOV-Immune (oncolytic vaccinia virus)
- Record updated
- 5 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors that kept growing after standard treatment, or that have no standard treatment. It tests a single IV infusion of IDOV-Immune, an oncolytic virus therapy.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced solid tumor, confirmed by tissue or cell tests. It has progressed despite standard therapy, or no standard therapy exists. The disease must be measurable (RECIST v1.1). ECOG performance status 1 or lower.
- Earlier treatment
- At least 28 days since major surgery, prior immunotherapy or radiotherapy (with exceptions for minor procedures). Prior treatment with an oncolytic virus is not allowed.
Main reasons for not taking part
- Prior treatment with an oncolytic virus
- Active or recent vaccinia virus infection, or smallpox/monkeypox vaccination within 10 years
- Active uncontrolled infection needing systemic treatment
- History of hepatitis B, hepatitis C or HIV (unless protocol-specific criteria are met)
- Active or untreated CNS metastases (unless stable per protocol)
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior treatment with an oncolytic virus
- Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions)
- Interstitial lung disease or prior pneumonitis requiring steroids
- 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)
- Active or symptomatic autoimmune disease requiring systemic therapy
- Significant cardiac disease (e.g., NYHA Class III/IV heart failure)
- 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
- Active or untreated CNS metastases (unless stable per protocol)
Where in United States
Also in 1 other country, 2 sites
- MD Anderson Cancer CenterHouston, United StatesContact: InvestigatorTaking people
- South Texas Accelerated Research TherapeuticsSan Antonio, United StatesContact: InvestigatorTaking people
- Washington University School of MedicineSt Louis, United StatesContact: Sara MitchumTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- IDOV-Immune Dose Escalation ArmTreatment being tested
Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity.
Treatment: IDOV-Immune (oncolytic vaccinia virus)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests IDOV-Immune, a virus therapy, in adults with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 August 2026