IDOV-Immune for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1 trial tests IDOV-Immune, a genetically engineered vaccinia oncolytic virus designed to infect and kill tumor cells and boost immune responses. The study uses a Bayesian Optimal Interval (BOIN) dose-escalation design to find the maximum tolerated dose and recommended Phase 2 dose while monitoring for dose-limiting toxicities over a 28-day period after dosing. Participants receive a single IV infusion on Day 1 of a 28-day cycle and undergo frequent safety checks, laboratory tests, imaging, and immune and pharmacokinetic/pharmacodynamic assessments. The trial is being run at multiple sites in the United States and Australia to collect early safety and preliminary activity data.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• South Texas Accelerated Research Therapeutics
  San Antonio, Texas, United States Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• The Alfred Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Study coordinator: Clinical Development
• Email: clinicaltrials@viromissile.com
• Phone: 858-886-7718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.