NCT06910657 IDOV-Immune for Advanced Solid Tumors
| NCT ID | NCT06910657 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ViroMissile, Inc. |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2025-08-25 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 serious thromboembolic events. * Any medical or psychiatric condition that could interfere with study participation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06910657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06910657 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06910657 currently recruiting?
Yes, NCT06910657 is actively recruiting participants. Contact the research team at clinicaltrials@viromissile.com for enrollment information.
Where is the NCT06910657 trial being conducted?
This trial is being conducted at St Louis, United States, Houston, United States, San Antonio, United States, Westmead, Australia and 1 additional location.
Who is sponsoring the NCT06910657 clinical trial?
NCT06910657 is sponsored by ViroMissile, Inc.. The trial plans to enroll 78 participants.
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