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 study about?

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.

1 Initial Treatment Phase

You will receive two medications through intravenous infusion (delivery of medicine directly into a vein):

– IOMX-0675 (a new antibody treatment)

– KEYTRUDA (pembrolizumab)

Your doctor will determine the exact dose based on your individual case and study requirements

2 Medical Evaluations

Regular health checks will monitor your condition, including:

Blood tests to check organ function and blood cell counts

Imaging scans to evaluate your tumor response to treatment

Assessment of any side effects you may experience

3 Tumor Biopsies

You will need to undergo tumor tissue sampling:

One biopsy before starting treatment

Additional biopsies during the course of treatment

These samples help evaluate how the treatment is affecting your tumor

4 Ongoing Treatment

Treatment will continue as long as:

Your cancer does not worsen

You do not experience severe side effects

You maintain adequate organ function as measured by regular tests

5 Follow-up Period

After completing treatment, you will need to:

Continue medical check-ups for at least 3 months

Use appropriate birth control methods during treatment and for 3 months after the last dose

Report any new health issues or side effects to your healthcare team

Who Can Join the Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
MD Anderson Cancer Center	Madrid	Spain
Hospital Quironsalud Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.07.2025

Trial locations

Investigated drugs:

Pembrolizumab

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.

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 ID:

2024-517449-14-00

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Study of IOMX-0675 alone or combined with pembrolizumab for patients with previously treated advanced or metastatic solid tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?