RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "IDOV-Immune will be administered as a single intravenous (IV) infusion on Day 1 of a 28-day treatment cycle."
  • "Participants will undergo frequent safety assessments, including physical exams, laboratory tests, imaging studies, and immune response monitoring."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (3)

MO

TX