Actively Recruiting
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
Led by ViroMissile, Inc. · Updated on 2026-03-02
78
Participants Needed
6
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IDOV-Immune, an investigational oncolytic vaccinia virus therapy, in adults with advanced solid tumors that have not responded to standard treatments or for which no standard therapy exists. This Phase I, first-in-human trial aims to determine the safety, tolerability, and highest safe dose of IDOV-Immune, as well as to study how the drug behaves in the body, immune responses, and preliminary signs of tumor shrinkage. The study is sponsored by ViroMissile, Inc. and conducted at multiple sites in the United States and Australia. Participants will receive a single intravenous infusion of IDOV-Immune on Day 1 of a 28-day treatment cycle. The study follows a dose-escalation design where each group of participants receives an increased dose based on safety and observed toxicities. Expansion cohorts may be enrolled at selected doses to further assess safety and anti-tumor activity. Safety monitoring includes frequent physical exams, lab tests, imaging, and immune response evaluations, along with pharmacokinetic and pharmacodynamic assessments. During the study, participants will be closely monitored for side effects and tumor changes. Assessments include laboratory tests, imaging studies, evaluation of immune and tumor biomarkers, and monitoring of drug levels in the body. The primary outcomes focus on dose-limiting toxicities, safety, and determination of the maximum tolerated dose. Secondary outcomes include measures of tumor response, progression-free survival, overall survival, and immune reaction to the virus. The total study duration includes a 28-day observation period with additional follow-up up to two years for some assessments.
CONDITIONS
Brief Title
IDOV-Immune for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced solid tumors that progressed despite standard therapy or have no standard therapy
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST v1.1
- Adequate organ and bone marrow function
- At least 28 days since major surgery, prior immunotherapy, or radiotherapy (minor procedures excepted)
- 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 will not qualify if you...
- Prior treatment with an oncolytic virus
- Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within the past 10 years
- Active uncontrolled infection requiring systemic treatment
- History of hepatitis B, hepatitis C, or HIV unless meeting protocol-specific criteria
- Unresolved grade 2 or higher toxicities from prior therapies except hair loss or stable chronic conditions
- Active or symptomatic autoimmune disease requiring systemic therapy
- Active or untreated central nervous system metastases unless stable per protocol
- Significant cardiac disease such as NYHA Class III or 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 recent serious thromboembolic events
- Any medical or psychiatric condition that could interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per treatment cycle
Participants receive a single intravenous infusion of the investigational IDOV-Immune virus on Day 1 of a 28-day cycle. The study follows a dose-escalation design to identify the recommended Phase 2 dose while monitoring safety and antitumor activity.
Frequent safety assessments including physical exams, laboratory tests, imaging studies, and immune response monitoring throughout the 28-day cycle
Duration - Up to 2 years
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity for up to 2 years after treatment.
Regular visits for safety and biomarker assessments, and monitoring of response and survival outcomes for up to 12 months, with safety follow-up extending to 90 days post-treatment
Trial Site Locations
Total: 6 locations
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
Not Yet Recruiting
5
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
6
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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