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2025-08-25
2027-01-31
2027-05-31
78
NCT06910657
ViroMissile, Inc.
ViroMissile, Inc.
INTERVENTIONAL
IDOV-Immune for Advanced Solid Tumors
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.
This is a first-in-human (FIH), Phase I, open-label, multi-center clinical trial designed to evaluate IDOV-Immune, an investigational oncolytic vaccinia virus-based immunotherapy, in adult participants with advanced solid tumors who have exhausted standard treatment options. IDOV-Immune is a genetically engineered vaccinia virus designed to selectively infect and destroy tumor cells while enhancing immune responses through the expression of immune-stimulating molecules. It has been further modified to improve tumor selectivity and minimize the risk of harming healthy cells. Study Design: The trial will follow a dose-escalation design to determine the maximum tolerated dose (MTD), the recommended Phase 2 dose (RP2D), and the overall safety and tolerability profile of IDOV-Immune. A Bayesian Optimal Interval (BOIN) design will guide dose-escalation decisions, based on observed dose-limiting toxicities (DLTs) during a 28-day observation period after the initial dose. The study will also assess preliminary signs of antitumor activity at each dose level. IDOV-Immune will be administered as a single intravenous (IV) infusion on Day 1 of a 28-day treatment cycle. Participants will undergo frequent safety assessments, including physical exams, laboratory tests, imaging studies, and immune response monitoring. Pharmacokinetics (how the virus behaves in the body), pharmacodynamics (how the virus impacts immune and tumor-related biomarkers), and immunogenicity (the body's immune response to the virus) will also be evaluated. Planned Enrollment and Cohorts: The study is expected to enroll up to approximately 42 participants in the dose-escalation phase. If appropriate, additional participants may be enrolled in backfill cohorts at selected dose levels to further assess the safety, biomarkers , and preliminary efficacy in specific populations. Across all study parts, total enrollment could reach approximately 78 participants. Study Objectives: The primary objective is to assess the safety and tolerability of IDOV-Immune and to determine the RP2D for future studies. Secondary objectives include evaluating how the investigational product moves through and affects the body (pharmacokinetics and pharmacodynamics), as well as initial signs of tumor response, including objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Rationale: There remains a significant unmet need for effective therapies for patients with advanced solid tumors who have progressed on or are intolerant to standard treatments. Oncolytic viruses have the potential for destroying cancer cells and activating anti-tumor immune responses. IDOV-Immune's multi-pronged design - combining direct oncolysis, immune recruitment, and immune system activation - aims to maximize therapeutic potential while maintaining an acceptable safety profile. Study Locations: The study will be conducted at multiple clinical sites in the United States and Australia with expertise in early-phase oncology trials and oncolytic virus therapies.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-03-21 | N/A | 2025-09-03 |
2025-03-27 | N/A | 2025-09-10 |
2025-04-04 | N/A | 2025-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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 receivi | BIOLOGICAL: IDOV-Immune (oncolytic vaccinia virus)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Dose-Limiting Toxicities (DLTs) | Number of participants experiencing dose-limiting toxicities during the first 28 days after IDOV-Immune infusion, assessed using NCI CTCAE v5.0. | First 28 days after treatment (Cycle 1) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Count of participants who experience treatment-emergent adverse events after receiving IDOV-Immune. | Up to 90 days post-treatment |
| Determination of Maximum Tolerated Dose (MTD) | Identification of the highest dose level at which ≤ 30% of participants experience DLTs. | Through completion of dose-escalation phase (~24 months) |
| Determination of Recommended Phase 2 Dose (RP2D) | Dose selected based on totality of safety, PK, PD, and efficacy data. | Through completion of dose-escalation and evaluation of all safety, PK/PD, and clinical activity data (~24 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Peak Whole Blood Viral Genome Copy Number | Measurement of the highest detected viral genome copy number in whole blood after administration of IDOV-Immune. | Up to 28 days post-infusion |
| Peak Serum Cytokine (IL-12 and CXCL9) Concentration | Measurement of the highest detected IL-12 and CXCL9 levels in serum after administration of IDOV-Immune. | Up to 28 days post-infusion |
| Serum Cytokine (IFN-β, IFN-γ, IL-1β, IL-6, IL-10, TNF-α, and TGF-β1) Concentration | Measurement of serum cytokine levels as a pharmacodynamic marker following IDOV-Immune administration. | Up to 28 days post-infusion |
| Objective Response Rate (ORR) | Percentage of participants with a best overall response of complete response (CR) or partial response (PR), assessed per RECIST v1.1. | Up to 12 months |
| Duration of Response (DOR) | Time from first documented objective response (CR or PR) to progression or death. | Up to 12 months |
| Disease Control Rate (DCR) | Proportion of participants achieving CR, PR, or stable disease (SD) lasting at least 8 weeks. | Up to 12 months |
| Progression-Free Survival (PFS) | Time from first dose to documented disease progression or death from any cause. | Up to 12 months |
| Overall Survival (OS) | Time from first dose to death from any cause. | Up to 12 months |
| Incidence of Neutralizing Antibody Response | Number of participants who develop detectable anti-vaccinia neutralizing antibodies after IDOV-Immune infusion. | Up to 90 days post-treatment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Clinical Development Phone Number: 858-886-7718 Email: clinicaltrials@viromissile.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
