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

Study Identifier:
VM-002-101
CT.gov Identifier:
NCT06910657
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bowel (Colorectal)
  • Pancreas
  • Melanoma
  • Ovarian
  • Gastric
  • Esophageal
  • Liver
  • Renal
  • Breast Cancers
  • Sarcoma
  • Bladder
  • Other Lung Cancer
  • Prostate
  • Cervical cancer
  • Head & Neck
  • Adrenal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: IDOV-Immune Dose Escalation Arm
    • Read More
  • Drug: 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.
  • Drug: Drug: IDOV-Immune (oncolytic vaccinia virus)
  • Drug: 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).
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Pancreas
    Melanoma
    Ovarian
    Gastric
    Esophageal
    Liver
    Renal
    Breast Cancers
    Sarcoma
    Bladder
    Other Lung Cancer
    Prostate
    Cervical cancer
    Head & Neck
    Adrenal