IDOV-Immune for advanced solid tumors

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

This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ViroMissile, Inc. (industry)
• Drugs / interventions: immunotherapy
• Locations: 6 sites (St Louis, Missouri and 5 other locations)
• Trial ID: NCT06910657 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label Phase 1 trial tests IDOV-Immune, a genetically engineered vaccinia oncolytic virus designed to infect and kill tumor cells and boost immune responses. The study uses a Bayesian Optimal Interval (BOIN) dose-escalation design to find the maximum tolerated dose and recommended Phase 2 dose while monitoring for dose-limiting toxicities over a 28-day period after dosing. Participants receive a single IV infusion on Day 1 of a 28-day cycle and undergo frequent safety checks, laboratory tests, imaging, and immune and pharmacokinetic/pharmacodynamic assessments. The trial is being run at multiple sites in the United States and Australia to collect early safety and preliminary activity data.

Who should consider this trial

Good fit: Adults (age ≥18) with histologically confirmed advanced solid tumors that have progressed after standard treatments, measurable disease, ECOG ≤1, and adequate organ and marrow function are the intended candidates.

Not a fit: Patients with prior oncolytic virus treatment, recent vaccinia/smallpox vaccination, active uncontrolled infections, certain chronic viral infections that fail protocol criteria, poor organ function, or pregnancy are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, IDOV-Immune could shrink tumors and stimulate durable anti-tumor immune responses in patients whose cancers no longer respond to standard therapies.

How similar studies have performed: Other oncolytic virus therapies (for example, T-VEC in melanoma) have shown clinical activity and safety in early trials, but this specific vaccinia-based construct is first-in-human and remains unproven.

Eligibility criteria

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.

Where this trial is running

St Louis, Missouri and 5 other locations

• Washington University School of Medicine — St Louis, Missouri, United States (NOT_YET_RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (NOT_YET_RECRUITING)
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (RECRUITING)
• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (NOT_YET_RECRUITING)
• Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Clinical Development

Conditions: Colorectal Cancer, Pancreatic Cancer, Melanoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma