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
1 other identifier
interventional
78
2 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Aug 2025
Shorter than P25 for phase_1 colorectal-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
April 4, 2025
CompletedStudy Start
First participant enrolled
August 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
March 2, 2026
February 1, 2026
1.4 years
March 21, 2025
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
From first dose through the end of the DLT evaluation period (28 days)
Safety and Tolerability of IDOV-Immune by Dose Level
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) 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)
Dose level(s) at which the observed incidence of dose-limiting toxicities meets protocol-defined criteria for maximum tolerated dose determination.
From first dose through completion of dose-escalation cohorts (2 years)
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.
From first dose through completion of dose-escalation and data review (2 years)
Secondary Outcomes (8)
Pharmacokinetic Parameters of IDOV-Immune by Dose Level
From first dose through completion of PK sampling (2 years)
Pharmacodynamic and Biomarker Responses Following IDOV-Immune Administration
From first dose through completion of biomarker assessments (2 years)
Objective Response Rate (ORR)
Up to 12 months
Duration of Response (DOR)
Up to 12 months
Disease Control Rate (DCR)
Up to 12 months
- +3 more secondary outcomes
Study Arms (1)
IDOV-Immune Dose Escalation Arm
EXPERIMENTALParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
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
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2025
First Posted
April 4, 2025
Study Start
August 25, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
March 2, 2026
Record last verified: 2026-02