IDOV-Immune for Advanced Solid Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
ViroMissile, Inc.
Study ID
NCT06910657
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: From first dose through the end of the DLT evaluation period (28 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Sara Mitchum
[email protected]
314-273-8602
MD Anderson Cancer CenterHoustonTexas77030
Investigator
[email protected]
877-632-6789
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229
Investigator
[email protected]
210-593-5250

Find similar trials in St Louis, MO

By condition
Bladder cancerBreast cancerColorectal cancerEsophageal cancerGastric cancerLiver cancerLung cancerMelanomaOvarian cancerPancreatic cancerProstate cancerKidney cancer
By specialty
OncologyUrologyBreast oncologyWomen's healthGI oncologyHepatologyLung oncologyLung diseaseSkin cancerDermatologyGynecologic oncologyProstate oncologyMen's health
By research site
Washington University School of Medicine· St Louis, MOMD Anderson Cancer Center· Houston, TXSouth Texas Accelerated Research Therapeutics· San Antonio, TX

Related Studies