Recruiting

IDOV-Immune for Advanced Solid Tumors

ClinicalTrials.gov IDNCT06910657

PhasePHASE1

Enrollment78

SponsorViroMissile, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Colorectal Cancer, Pancreatic Cancer, Melanoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma, Breast Cancer, Sarcoma, Bladder Cancer, Lung Cancer, Prostate Cancer, Cervical Cancers, Head and Neck Cancers, Adrenal Gland Tumors

About this study

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.

Interventions

Biological: 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 outcomes

Incidence of Dose-Limiting Toxicities (DLTs) (From first dose through the end of the DLT evaluation period (28 days))
Safety and Tolerability of IDOV-Immune by Dose Level (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) (From first dose through completion of dose-escalation cohorts (2 years))
Identification of Dose Level(s) for Further Clinical Evaluation (From first dose through completion of dose-escalation and data review (2 years))

Eligibility information

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 locations

Washington University School of Medicine, St Louis, Missouri 63110 United States
MD Anderson Cancer Center, Houston, Texas 77030 United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas 78229 United States
Westmead Hospital, Westmead, New South Wales 2145 Australia
The Alfred Hospital, Melbourne, Victoria 3004 Australia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.