Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain
Not yet recruiting
Study of IOMX-0675 alone or combined with pembrolizumab for patients with previously treated advanced or metastatic solid tumors
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on patients with advanced/metastatic solid tumors. The research evaluates two medications: IOMX-0675, a new antibody treatment, and pembrolizumab (also known as Keytruda). The purpose is to determine the most appropriate dose of IOMX-0675 when used alone or in combination with pembrolizumab in patients whose cancer has already been treated with other therapies.
The study involves two treatment approaches. In the first approach, some patients will receive IOMX-0675 by itself. This includes patients with specific types of cancer such as non-small cell lung cancer, gastric cancer, mesothelioma, or kidney cancer. In the second approach, patients with colorectal cancer will receive both IOMX-0675 and pembrolizumab together. Both medications are given through infusion, which means they are administered directly into a vein.
During the study, patients will receive treatment for up to 99 weeks. The maximum daily dose of IOMX-0675 will be 1800 milligrams, while pembrolizumab will be given at doses up to 200 milligrams. Doctors will monitor how patients respond to the treatment and check for any side effects. They will also perform various tests to understand how the medications work in the body.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Must be at least 18 years old or of legal age to consent in your country
- For single drug treatment: Must have confirmed diagnosis of one of these cancers: - Non-small cell lung cancer with previous treatment - Stomach or gastro-esophageal cancer with previous treatment - Mesothelioma with previous treatment - Kidney cancer with previous treatment
- For combination treatment: Must have advanced colorectal cancer that has been previously treated
- Must have cancer that is locally advanced, cannot be operated on, or has spread to other parts of the body
- Must have received at least one previous cancer treatment
- Must have good physical function (ECOG score of 0 or 1, meaning able to perform daily activities)
- Must agree to use birth control during treatment and for 3 months after the last dose
- Must have recovered from side effects of previous treatments (except for hair loss or managed hormone conditions)
- Must have adequate organ function, including: - Sufficient blood cell counts - Normal liver function - Normal kidney function - No blood transfusions in past 2 weeks
- Must have at least one tumor that can be measured for treatment response
- Must be willing to undergo tumor biopsies before and during treatment
Who cannot join the trial?
12 criteria
- History of severe allergic reactions to medications or other substances
- Active or untreated brain metastases (cancer that has spread to the brain)
- Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
- Uncontrolled or severe heart, lung, kidney, or liver diseases
- Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
- Previous treatment with similar experimental medications within 4 weeks before starting the study
- Participation in other clinical trials within 4 weeks before this study
- Pregnant or breastfeeding women
- Major surgery within 4 weeks before starting the study
- Any condition that, in the opinion of the study doctor, would make participation unsafe
- Unable to understand or sign the informed consent form
- History of other cancers within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Hospital Universitario Hm Sanchinarro
ResponsiveMadrid, SpainHospital Universitario Quironsalud Madrid
VerifiedPozuelo De Alarcon, Spain
Trial locations
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Investigated drugs
IOMX-0675
is an experimental treatment that belongs to a class of medications called monoclonal antibodies. It works by blocking specific proteins called LILRB1/2, which may help the immune system fight cancer cells. This is being tested as a new treatment for patients with advanced or spreading solid tumors.
Pembrolizumab
is an immunotherapy medication that helps the body's immune system detect and fight cancer cells. It works by blocking a protein called PD-1 that can prevent the immune system from attacking cancer cells. It's already approved for treating several types of cancer and in this trial is being tested in combination with IOMX-0675.
What is already known about the treatment
IOMX-0675
A fully human monoclonal antibody administered through intravenous infusion that selectively inhibits LILRB1/2 receptors. Currently undergoing Phase I/II clinical trials for the treatment of advanced and metastatic solid tumors, this medication represents a novel approach in immunotherapy. The drug works by blocking immune checkpoint receptors LILRB1 and LILRB2, potentially enhancing the body's immune response against cancer cells.
Pembrolizumab
An established immunotherapy medication administered intravenously that belongs to the class of PD-1 inhibitors. This monoclonal antibody is approved for treating various types of advanced cancers by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. In this clinical trial, it is being studied in combination with IOMX-0675 to potentially enhance the anti-tumor immune response in patients with advanced or metastatic solid tumors.
Investigated diseases
Advanced/Metastatic Solid Tumors - A condition where cancer cells have spread from their original location to other parts of the body through the bloodstream or lymphatic system. In this state, tumors (abnormal masses of tissue) have formed in organs or tissues distant from the primary tumor site. The disease is characterized by the growth of solid masses of cancer cells that can affect various body systems. These tumors can develop in multiple locations simultaneously and continue to grow over time. The condition typically progresses through the development of new tumor sites and the expansion of existing masses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517449-14-00Estimated enrolment110 patientsSponsoriOmx Therapeutics AG
sourced from the EU Clinical Trials Register and site verification
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