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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland

Other Sites

Site Name	City	Country
Hospital Clinic De Barcelona	Barcelona	Spain
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Pratia S.A.	Skorzewo	Poland
Ikjvjtyf Cslyvs Dwjellvgnfpapfsrx	L'hospitalet De Llobregat	Spain
Axchrkdcm Ueo	Amsterdam	The Netherlands
Eatdnlu Umluvdysjqbq Mikrzgi Cggpmul Rctgvauhh (wojhquy Mqo	Rotterdam	The Netherlands
Iwbwkgvw Pcnsqohivjuydur Cjdmeg Cpvfdc	Marseille	France
Cpvwwn Obeqp Loylqzf	Lille	France
Nzzoxfng Ilgjvikm Ogripbqbl Ipq Mpdzp Swbywmiminswtjidlsxloiyazvdk Iuykolas Byosnrze	Cracow	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.05.2025
Poland	Recruiting	15.05.2025
Spain	Recruiting	15.05.2025
The Netherlands	Recruiting	15.05.2025

Trial locations

Investigated drugs:

SKB410

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.

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.

Trial ID:

2024-516817-19-00

Protocol code:

MK-3120-002

Trial Phase:

Human Pharmacology (Phase I) – Other

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?