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RecruitingLast updated: 20 April 2026

IDOV-IMMUNE: This study is recruiting people with advanced solid cancers to test the safety and effect of a virus-based immunotherapyA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

IDOV-IMMUNE

Clinical summary

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 tumours 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 tumour.

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 tumours.

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.

Conditions

This trial is treating people with advanced solid cancers that have progressed despite standard therapy or for which no standard therapy exists

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

ViroMissile, Inc.

Scientific 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

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