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.
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.
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).
Sequential
IDOV-Immune (oncolytic vaccinia virus)
Biological/VaccineIDOV-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).
Incidence of Dose-Limiting Toxicities (DLTs)
The number and proportion of participants experiencing dose-limiting toxicities (DLTs), assessed by dose level during the DLT evaluation period. DLTs are defined per protocol-specified criteria and graded according to CTCAE.
Safety and Tolerability of IDOV-Immune by Dose Level
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) by dose level.
Determination of the Maximum Tolerated Dose (MTD)
Dose level(s) at which the observed incidence of dose-limiting toxicities meets protocol-defined criteria for maximum tolerated dose determination.
Identification of Dose Level(s) for Further Clinical Evaluation
Dose level(s) selected for further clinical evaluation based on integrated safety, tolerability, and pharmacokinetic data, as defined in the protocol.
Pharmacokinetic Parameters of IDOV-Immune by Dose Level
Pharmacokinetic parameters including, but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC), time to maximum concentration (Tmax), and half-life (t½), summarized by dose level.
Pharmacodynamic and Biomarker Responses Following IDOV-Immune Administration
Changes in protocol-specified pharmacodynamic and exploratory biomarker endpoints over time, summarized by dose level.
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.
Duration of Response (DOR)
Time from first documented objective response (CR or PR) to progression or death.
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