NCT06910657RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- 25 Aug 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- ViroMissile, Inc.
- Diseases
- Prostate cancer, Kidney cancer, Bladder cancer, Melanoma, Cervical cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT06910657
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 78
- From 25 Aug 2025 to the primary completion date, 31 Jan 2027
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Active or untreated CNS metastases (unless stable per protocol).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| South Texas Accelerated Research Therapeutics Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.