Recruiting

Study on the Safety and Effects of MK-3120 for Patients with Advanced Solid Tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for people with advanced solid tumors. Solid tumors are a type of cancer that forms in solid organs or tissues, such as the breast, lung, or prostate. The treatment being tested in this study is called MK-3120, which is a solution given by injection or infusion. The main goal of the study is to evaluate the safety and tolerability of MK-3120 when used alone.

Participants in the study will receive MK-3120 to see how their bodies respond to the treatment. The study will monitor the number of participants who experience any side effects and those who may need to stop the treatment due to these effects. Additionally, the study will look at how well the treatment works by measuring the response rate, how long the response lasts, and the overall survival of participants. The study will also track how the drug moves through the body, including its concentration levels over time.

This study is open-label, meaning both the researchers and participants know what treatment is being given. It is designed to help understand the potential benefits and risks of MK-3120 for people with advanced solid tumors who have already tried other treatments without success. The study is expected to continue until early 2028, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. This study is designed to evaluate the safety and effectiveness of MK-3120 in individuals with advanced solid tumors.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying that you have an advanced solid tumor and have received or been intolerant to all available treatments. If applicable, your HIV, hepatitis B, or hepatitis C status will be reviewed to ensure it is well controlled.
Step 3
Treatment administration
You will receive MK-3120 as a solution for injection or infusion. The specific dosage, frequency, and duration of administration will be determined by the study team based on your individual condition and response to the treatment.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will occur to assess your response to the treatment and any side effects. This includes measuring the concentration of MK-3120 in your blood at various times to understand how your body processes the medication.
Step 5
End of study participation
Your participation in the study will continue until the study's estimated end date or until you decide to withdraw. The study aims to complete by January 21, 2028. At the end of your participation, a final assessment will be conducted to evaluate your overall health and response to the treatment.

Who can join the trial?

5 criteria

Must have a confirmed advanced (cannot be removed by surgery) and/or metastatic (cancer has spread to other parts of the body) solid tumor and have received or been intolerant to all available treatments.
If HIV positive (has the human immunodeficiency virus), must have well-controlled HIV on antiretroviral therapy (ART), which is medication to manage HIV.
If hepatitis B surface antigen (HBsAg) positive (has hepatitis B), must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have an undetectable HBV viral load, meaning the virus is not detectable in the blood.
If hepatitis C virus (HCV) infected (has hepatitis C), must have an undetectable HCV viral load, meaning the virus is not detectable in the blood.
Open to both male and female participants.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to any of the ingredients in the study medication cannot participate.
Patients who are currently pregnant or breastfeeding are not eligible for the study.
Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, that are not well-managed with medication cannot join the study.
Patients who have participated in another clinical trial within the last 30 days are not allowed to participate.
Patients with a history of drug or alcohol abuse within the past year are excluded from the study.
Patients with active infections, such as hepatitis or HIV, are not eligible to participate.
Patients who have had a major surgery within the last 4 weeks cannot join the study.
Patients with a known history of heart disease, such as heart attack or heart failure, are excluded from the study.
Patients who are unable to comply with the study procedures and follow-up visits are not eligible.
Patients with any other medical condition that the study doctors believe would make participation unsafe are not allowed to join the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

MK-3120 is a new medication being tested to see if it is safe and how well it works for people with advanced solid tumors. This medication is being studied to understand its effects when used by itself, without combining it with other treatments. The main goal is to find out if it can be used safely and if it helps in treating the tumors. Participants in the trial will receive this medication, and researchers will closely monitor them to see how their bodies respond and to check for any side effects.

SKB410

What is already known about the treatment

MK-3120 – MK-3120 is administered as a monotherapy for individuals with advanced or metastatic solid tumor diseases. Currently, it is being studied in clinical trials to assess its safety and effectiveness, and it is not yet widely available in medical practice. The main therapeutic goal of MK-3120 is to treat advanced solid tumors, which are cancers that have spread beyond their original site. At the molecular level, MK-3120 works by targeting specific pathways in cancer cells to inhibit their growth and spread. It is classified pharmacologically as an investigational cancer treatment.

Investigated diseases

Advanced/metastatic solid tumor disease – This condition involves the presence of solid tumors that have progressed to an advanced stage or have spread to other parts of the body, known as metastasis. Solid tumors are abnormal masses of tissue that can occur in various organs, such as the lungs, liver, or pancreas. As the disease progresses, these tumors can grow larger and invade nearby tissues. Metastatic tumors can travel through the bloodstream or lymphatic system to form new tumors in distant organs. The progression of the disease can lead to a variety of symptoms depending on the location and size of the tumors. The condition is characterized by the body's inability to control the growth and spread of these abnormal cells.