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IDOV-Immune for Advanced Solid Tumors

This study is testing a new treatment called IDOV-Immune for adults with advanced solid tumors like colorectal, pancreatic, melanoma, ovarian, or gastric cancer. These are cancers that have not responded to standard treatments or for which no standard treatment exists. IDOV-Immune is a special virus designed to infect and destroy cancer cells, and it may also help your immune system fight the cancer. This is a first-in-human (Phase 1) study, meaning it's the first time this treatment is being given to people. The main goals are to find out if IDOV-Immune is safe, how well people tolerate it, and to determine the highest dose that can be given safely. Researchers will also look for any signs that the treatment is shrinking tumors. The study is currently recruiting about 78 participants.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know what treatment you are receiving. It will enroll about 78 participants to find the safest dose.
What's involved
You would receive a single intravenous (IV) infusion of IDOV-Immune. You will have frequent safety checks, including physical exams, lab tests, and imaging studies, for at least 28 days and potentially up to 90 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for at least 90 days after your first dose.

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NCT06910657

IDOV-Immune for Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
ViroMissile, Inc.
~78 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:IDOV-Immune (oncolytic vaccinia virus)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs)
Measured over From first dose through the end of the DLT evaluation period (28 days)
+3 more outcomes measured

Conditions

Colorectal Cancer
Pancreatic Cancer
Melanoma
Ovarian Cancer
Gastric Cancer
Esophageal Cancer
Hepatocellular Carcinoma
Renal Cell Carcinoma
Breast Cancer
Sarcoma
Bladder Cancer
Lung Cancer
Prostate Cancer
Cervical Cancers
Head and Neck Cancers
Adrenal Gland Tumors

Explore related trials

Adrenal Gland NeoplasmBladder CarcinomaBreast CarcinomaCervical CarcinomaColorectal CarcinomaEsophageal CarcinomaGastric CarcinomaHepatocellular CarcinomaLung CarcinomaMalignant Head and Neck NeoplasmMalignant Ovarian NeoplasmMelanomaPancreatic CarcinomaProstate CarcinomaRenal Cell CarcinomaSarcomaSolid Neoplasm

Where it's being run

5 sites across 4 states
Texas2
Missouri1
New South Wales1
Victoria1

Who to contact

Clinical Development
[email protected]
858-886-7718
Email the study team

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Eligibility criteria

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.

What this trial measures

  • Incidence of Dose-Limiting Toxicities (DLTs)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.

  • Safety and Tolerability of IDOV-Immune by Dose LevelFrom 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.

  • Determination of the Maximum Tolerated Dose (MTD)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.

  • Identification of Dose Level(s) for Further Clinical EvaluationFrom 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.