IDOV-Immune for Advanced Solid Tumors (NCT06910657) | Clinical Trial Compass
RecruitingPhase 1
IDOV-Immune for Advanced Solid Tumors
United States, Australia78 participantsStarted 2025-08-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* 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.
Key Exclusion Criteria:
* 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 se…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the maximum tolerated dose and measuring dose-limiting toxicities, what does that mean in practical terms for my safety, and how does being in an early dose-finding study differ from receiving a treatment where safety is already well established?
2Given that IDOV-Immune is being tested across a wide range of cancers including mine, would you say there's any early evidence specific to my cancer type that makes this worth considering, or is the data still very preliminary at this stage?
3What are the dose-limiting toxicities they're watching for in this trial, and based on what's known so far, are there particular side effects I should be prepared to discuss before deciding whether this fits my situation?
4Before considering this trial, is there a standard treatment or an approved immunotherapy option I should try first, or has my cancer reached a point where a Phase 1 study like this might be a reasonable path to explore?
5How often would I need to come in for monitoring and assessments given that this trial is actively tracking safety at each dose level, and is that schedule realistic given my current health and day-to-day responsibilities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: From first dose through the end of the DLT evaluation period (28 days)
2
Safety and Tolerability of IDOV-Immune by Dose Level
Timeframe: From first dose through end of treatment (28 days) (and/or safety follow-up period as defined in protocol [90 days])
3
Determination of the Maximum Tolerated Dose (MTD)
Timeframe: From first dose through completion of dose-escalation cohorts (2 years)
4
Identification of Dose Level(s) for Further Clinical Evaluation
Timeframe: From first dose through completion of dose-escalation and data review (2 years)