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NCT Number: NCT06910657

IDOV-Immune for 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.

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Key information

Conditions

Colorectal Cancer Adenocarcinoma Adnexal Diseases Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenal Gland Tumors Bladder Cancer Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Cervical Cancers Colonic Diseases Colorectal Neoplasms DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Cancers Head and Neck Neoplasms Hepatocellular Carcinoma Infections Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Poxviridae Infections Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaccinia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Westmead Hospital, Westmead, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDOV-Immune (oncolytic vaccinia virus)

Biological

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Duration of Response (DOR)

    Time frame: Up to 12 months

    Time from first documented objective response (CR or PR) to progression or death.

  5. 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.

  6. Progression-Free Survival (PFS)

    Time frame: Up to 12 months

    Time from first dose to documented disease progression or death from any cause.

  7. Overall Survival (OS)

    Time frame: Up to 12 months

    Time from first dose to death from any cause.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Development

CONTACT

[email protected]

858-886-7718

Sponsors and collaborators

Lead sponsor

ViroMissile, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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