IDOV-Immune for Advanced Solid Tumors

February 27, 2026 updated by: ViroMissile, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a first-in-human (FIH), Phase I, open-label, multi-center clinical trial designed to evaluate IDOV-Immune, an investigational oncolytic vaccinia virus-based immunotherapy, in adult participants with advanced solid tumors who have exhausted standard treatment options.

IDOV-Immune is a genetically engineered vaccinia virus designed to selectively infect and destroy tumor cells while enhancing immune responses through the expression of immune-stimulating molecules. It has been further modified to improve tumor selectivity and minimize the risk of harming healthy cells.

Study Design:

The trial will follow a dose-escalation design to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the overall safety and tolerability profile of IDOV-Immune. A Bayesian Optimal Interval (BOIN) design will guide dose-escalation decisions, based on observed dose-limiting toxicities (DLTs) during a 28-day observation period after the initial dose. The study will also assess preliminary signs of antitumor activity at each dose level.

IDOV-Immune will be administered as a single intravenous (IV) infusion on Day 1 of a 28-day treatment cycle. Participants will undergo frequent safety assessments, including physical exams, laboratory tests, imaging studies, and immune response monitoring. Pharmacokinetics (how the virus behaves in the body), pharmacodynamics (how the virus impacts immune and tumor-related biomarkers), and immunogenicity (the body's immune response to the virus) will also be evaluated.

Planned Enrollment and Cohorts:

The study is expected to enroll up to approximately 42 participants in the dose-escalation phase. If appropriate, additional participants may be enrolled in backfill cohorts at selected dose levels to further assess the safety, biomarkers , and preliminary efficacy in specific populations. Across all study parts, total enrollment could reach approximately 78 participants.

Study Objectives:

The primary objective is to assess the safety and tolerability of IDOV-Immune and to determine the RP2D for future studies. Secondary objectives include evaluating how the investigational product moves through and affects the body (pharmacokinetics and pharmacodynamics), as well as initial signs of tumor response, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).

Rationale:

There remains a significant unmet need for effective therapies for patients with advanced solid tumors who have progressed on or are intolerant to standard treatments. Oncolytic viruses have the potential for destroying cancer cells and activating anti-tumor immune responses. IDOV-Immune's multi-pronged design - combining direct oncolysis, immune recruitment, and immune system activation - aims to maximize therapeutic potential while maintaining an acceptable safety profile.

Study Locations:

The study will be conducted at multiple clinical sites in the United States and Australia with expertise in early-phase oncology trials and oncolytic virus therapies.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDOV-Immune Dose Escalation Arm
Participants in this arm will receive a single intravenous (IV) infusion of IDOV-Immune, an investigational oncolytic vaccinia virus, on Day 1 of a 28-day treatment cycle. The study will follow a dose-escalation design, with each successive cohort receiving an increased dose based on safety data and observed dose-limiting toxicities (DLTs). Following dose escalation, expansion cohorts may be enrolled at selected dose levels to further assess safety and preliminary antitumor activity.
Biological: IDOV-Immune (oncolytic vaccinia virus)
IDOV-Immune is a genetically engineered oncolytic vaccinia virus designed to selectively infect and destroy tumor cells while stimulating the immune system. This study investigates IDOV-Immune as a single intravenous infusion in a first-in-human, Phase 1, dose-escalation trial in participants with advanced solid tumors. The dose will escalate based on safety data, with a goal of identifying the recommended Phase 2 dose (RP2D).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame: From first dose through the end of the DLT evaluation period (28 days)
The number and proportion of participants experiencing dose-limiting toxicities (DLTs), assessed by dose level during the DLT evaluation period. DLTs are defined per protocol-specified criteria and graded according to CTCAE.
From first dose through the end of the DLT evaluation period (28 days)
Safety and Tolerability of IDOV-Immune by Dose Level
Time Frame: From first dose through end of treatment (28 days) (and/or safety follow-up period as defined in protocol [90 days])
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) by dose level.
From first dose through end of treatment (28 days) (and/or safety follow-up period as defined in protocol [90 days])
Determination of the Maximum Tolerated Dose (MTD)
Time Frame: From first dose through completion of dose-escalation cohorts (2 years)
Dose level(s) at which the observed incidence of dose-limiting toxicities meets protocol-defined criteria for maximum tolerated dose determination.
From first dose through completion of dose-escalation cohorts (2 years)
Identification of Dose Level(s) for Further Clinical Evaluation
Time Frame: From first dose through completion of dose-escalation and data review (2 years)
Dose level(s) selected for further clinical evaluation based on integrated safety, tolerability, and pharmacokinetic data, as defined in the protocol.
From first dose through completion of dose-escalation and data review (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 12 months
Percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed per RECIST v1.1.
Up to 12 months
Duration of Response (DOR)
Time Frame: Up to 12 months
Time from first documented objective response (CR or PR) to progression or death.
Up to 12 months
Disease Control Rate (DCR)
Time Frame: Up to 12 months
Proportion of participants achieving CR, PR, or stable disease (SD) lasting at least 8 weeks.
Up to 12 months
Progression-Free Survival (PFS)
Time Frame: Up to 12 months
Time from first dose to documented disease progression or death from any cause.
Up to 12 months
Overall Survival (OS)
Time Frame: Up to 12 months
Time from first dose to death from any cause.
Up to 12 months
Incidence of Neutralizing Antibody Response
Time Frame: Up to 90 days post-treatment
Number of participants who develop detectable anti-vaccinia neutralizing antibodies after IDOV-Immune infusion.
Up to 90 days post-treatment
Pharmacokinetic Parameters of IDOV-Immune by Dose Level
Time Frame: From first dose through completion of PK sampling (2 years)
Pharmacokinetic parameters including, but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), and half-life (t½), summarized by dose level.
From first dose through completion of PK sampling (2 years)
Pharmacodynamic and Biomarker Responses Following IDOV-Immune Administration
Time Frame: From first dose through completion of biomarker assessments (2 years)
Changes in protocol-specified pharmacodynamic and exploratory biomarker endpoints over time, summarized by dose level.
From first dose through completion of biomarker assessments (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViroMissile, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VM-002-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on IDOV-Immune (oncolytic vaccinia virus)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe