Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Drug Absorption Study of MK-3475A in Participants with Solid Tumors

This research study is about a new drug called MK-3475A. It focuses on how well the body takes in and uses this drug, specifically in people who have advanced or metastatic solid tumours. Think of it like seeing how a sponge soaks up water – the study wants to understand how the body absorbs the medicine after it's given. This is an early-stage study, meaning it’s one of the first times this drug is being tested in humans. The main goal is to find out how the drug moves through the body, which helps researchers decide the best way to give it in the future. Anyone aged 18 or older, male or female, who has been diagnosed with an advanced solid tumour might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

11 Oct 2023

Advanced or Metastatic Solid Tumors

What is this study about?

This study is investigating a new medicine called MK-3475A. The main purpose is to understand how your body handles this drug. When you take a medicine, your body absorbs it, uses it, and then gets rid of it. This process is called drug absorption, distribution, metabolism, and excretion – but we're mainly focusing on the absorption part here. Researchers want to know how much of the drug gets into your bloodstream, how quickly it gets there, and how long it stays in your system. This information is really important because it helps scientists figure out the best way to give the drug and the right dose for future studies. They're still learning basic things about this drug in people.

This is an early-stage study, often called a Phase I study. This means it's generally one of the first times the drug is being given to people. Because it's so early, the study is mainly focused on safety and how the drug behaves in the body, rather than on whether it cures the cancer. By carefully studying how MK-3475A is absorbed, researchers can make informed decisions about how to develop it further.

The study involves people who have advanced or metastatic solid tumours. 'Advanced' means the cancer has grown or spread, and 'metastatic' means it has spread from where it started to other parts of the body. While this study isn't directly looking at treating the cancer, understanding how the drug works in people with these conditions is a vital step in deciding if it could be a useful treatment in the future. Every step in drug development, including these early absorption studies, is crucial for bringing new potential medicines to patients.

Key takeaways

This study is about a new drug (MK-3475A) for advanced solid tumours.
It focuses on how your body absorbs and processes the drug.
It's an early-stage study (Phase I) for safety and understanding the drug's behaviour.
Participants must be adults (18+) with advanced or metastatic solid tumours.
Participation involves taking the drug, regular blood tests, and medical check-ups.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There's no upper age limit mentioned, so older adults might also be able to take part.

This study is for both men and women. The main medical condition required is a diagnosis of advanced or metastatic solid tumours. This means you have cancer that has grown or spread from its original site to other parts of your body.

Keep in mind, there will be other specific health requirements and tests to check if this study is right for you. Your doctor will be able to explain these in more detail, as the full list of who can and cannot join is not provided here.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with an advanced or metastatic solid tumour?
Are you able to attend appointments for blood tests and monitoring?
Are you comfortable potentially trying a new, investigational drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to a clinic or hospital. These visits would involve being given the study drug, MK-3475A. You might receive the drug in different ways, or at different times, to help researchers understand its absorption.

You would have regular blood tests to measure the levels of the drug in your body. This is a key part of understanding how your body absorbs it. There might also be other tests, like urine samples, and check-ups to monitor your general health and make sure you are feeling well. The study aims to gather detailed information about the drug's journey through your system.

The total duration of your participation, including how many visits and how long they last, is not specified here but would be fully explained by the study team. There would also be a follow-up period after you stop taking the study drug to ensure your health is monitored.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of this study is that you would be among the first to receive this new investigational drug, which could help advance medical knowledge for future cancer treatments. You would also receive close medical attention and monitoring. However, because this is a new drug, there's always a chance of experiencing side effects that are not yet fully known, ranging from mild to more serious. The study team will carefully monitor you for any side effects and explain all known risks. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
Hungary

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that doesn't contain cysts or liquid areas. Most cancers, like those of the breast, lung, or bowel, are solid tumours.

What does 'advanced or metastatic' mean?

This means the cancer has grown or spread from where it started to other parts of the body. 'Metastatic' specifically refers to this process of spreading.

What does 'drug absorption study' mean?

It means the study focuses on how your body takes in the medicine, how much gets into your bloodstream, and how your body processes it. It helps find the best way to give the drug.

Is this a new treatment for my cancer?

This is an early-stage study focusing on how the drug works in the body rather than directly treating your cancer. It's a step towards understanding if it could become a treatment in the future.

Will I receive any personal benefit from taking part?

There's no guarantee of direct personal benefit from an absorption study. The main benefit is contributing to medical knowledge that could help others in the future.