Status:
RECRUITING
IDOV-Immune for Advanced Solid Tumors
Lead Sponsor:
ViroMissile, Inc.
Conditions:
Colorectal Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 standar...
Detailed Description
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 participant...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06910657
Start Date
August 25 2025
End Date
May 31 2027
Last Update
December 17 2025
Active Locations (6)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
4
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065