RECRUITING

IDOV-Immune for Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-25
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06910657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.
  3. * ECOG performance status ≤ 1.
  4. * Measurable disease per RECIST v1.1.
  5. * Adequate organ and bone marrow function.
  6. * At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).
  7. * Negative pregnancy test for women of childbearing potential.
  8. * Agreement to use effective contraception during treatment and for 3 months after.
  9. * Ability to provide informed consent and comply with study requirements.
  1. * Prior treatment with an oncolytic virus.
  2. * Active or recent vaccinia virus infection or smallpox/monkeypox vaccination within 10 years.
  3. * Active uncontrolled infection requiring systemic treatment.
  4. * History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).
  5. * Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).
  6. * Active or symptomatic autoimmune disease requiring systemic therapy.
  7. * Active or untreated CNS metastases (unless stable per protocol).
  8. * Significant cardiac disease (e.g., NYHA Class III/IV heart failure).
  9. * Interstitial lung disease or prior pneumonitis requiring steroids.
  10. * Conditions requiring chronic immunosuppressive therapy.
  11. * Severe skin disorders or history of pancreatitis.
  12. * Bleeding disorders or history of recent serious thromboembolic events.
  13. * Any medical or psychiatric condition that could interfere with study participation.

Contacts and Locations

Study Contact

Clinical Development
CONTACT
858-886-7718
clinicaltrials@viromissile.com

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: ViroMissile, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2025-08-25
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Oncolytic Virus Therapy
  • Advanced Solid Tumors
  • Metastatic Cancer
  • Refractory Cancer
  • Immunotherapy
  • Vaccinia Virus

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Pancreatic Cancer
  • Melanoma
  • Ovarian Cancer
  • Gastric Cancer
  • Esophageal Cancer
  • Hepatocellular Carcinoma
  • Renal Cell Carcinoma
  • Breast Cancer
  • Sarcoma
  • Bladder Cancer
  • Lung Cancer
  • Prostate Cancer
  • Cervical Cancers
  • Head and Neck Cancers
  • Adrenal Gland Tumors