Recruiting
Phase 1

IDOV-Immune

Sponsor:

ViroMissile, Inc.

Code:

NCT06910657

Conditions

Colorectal Cancer

Pancreatic Cancer

Melanoma

Ovarian Cancer

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IDOV-Immune (oncolytic vaccinia virus)

Study Details

Brief 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.

Conditions

Colorectal Cancer

Pancreatic Cancer

Melanoma

Ovarian Cancer

Gastric Cancer

Study ID

NCT06910657

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

78 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: 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]) ]
  • Determination of the Maximum Tolerated Dose (MTD) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Clinical Development

858-886-7718clinicaltrials@viromissile.com

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Mitchum

314-273-8602saram@wustl.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Investigator

877-632-6789physicianreferrals@mdanderson.org

South Texas Accelerated Research Therapeutics

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Investigator

210-593-5250information@startresearch.com

More Information

Sponsor

ViroMissile, Inc.

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Oncolytic Virus Therapy
  • Advanced Solid Tumors
  • Metastatic Cancer
  • Refractory Cancer
  • Immunotherapy
  • Vaccinia Virus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ViroMissile, Inc. on 2026-08-05.