IDOV-Immune for Advanced Solid Tumors

Launched by VIROMISSILE, INC. · Mar 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IDOV-Immune for adults with advanced solid tumors, such as colorectal, pancreatic, and breast cancers, that have not improved with standard therapies. IDOV-Immune is a type of oncolytic virus therapy, which means it is designed to infect and kill cancer cells while also helping the immune system to fight the cancer. The trial aims to find out how safe this treatment is, how well patients tolerate it, and whether it can help shrink tumors.

To join the study, participants must be at least 18 years old and have a confirmed diagnosis of advanced solid tumors that have continued to grow despite previous treatments. They should be in good overall health and able to follow the study requirements. Participants will receive one infusion of IDOV-Immune through an IV and will be closely monitored for side effects and any changes in their cancer. The trial is currently not recruiting patients, and it is taking place at multiple locations in the United States and Australia.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 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 Criteria:
• • 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.