IDOV-Immune for Advanced Solid Tumors

Phase

Condition

Ovarian Cancer

Pancreatic Cancer

Lung Disease

Treatment

IDOV-Immune (oncolytic vaccinia virus)

Clinical Study ID

NCT06910657

VM-002-101

Ages > 18
All Genders

Study 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

Inclusion

Key Inclusion Criteria:

Age ≥ 18 years.
Histologically or cytologically confirmed advanced solid tumors that have progresseddespite 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 (withexceptions 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

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-specificcriteria).
Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stablechronic 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 Design

IDOV-Immune (oncolytic vaccinia virus)

August 25, 2025

May 31, 2027

Study 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.

Connect with a study center

Westmead Hospital
Westmead, New South Wales 2145
Australia
Site Not Available
Royal North Shore Hospital
Saint Leonards, New South Wales 2155400 2065
Australia
Site Not Available
Westmead Hospital
Westmead 2143973, New South Wales 2155400 2145
Australia
Active - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
Australia
Site Not Available
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 3004
Australia
Active - Recruiting
Washington University School of Medicine
St. Louis, Missouri 63110
United States
Site Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United States
Site Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United States
Site Not Available
South Texas Accelerated Research Therapeutics
San Antonio, Texas 78229
United States
Site Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United States
Site Not Available
South Texas Accelerated Research Therapeutics
San Antonio 4726206, Texas 4736286 78229
United States
Active - Recruiting

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