A Phase 1, Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MK-4464 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced/Metastatic Solid Tumors
This is an early-stage medical study, called a Phase 1 trial, looking into a new treatment named MK-4464. It comes in two parts: first, MK-4464 is given by itself, and then it's given together with a standard cancer drug called pembrolizumab. The study is for adults who have advanced or metastatic solid tumours, which means their cancer has spread. The main goals are to check if MK-4464 is safe, how much of it stays in the body over time, and what effects it has on the body. This is important foundational research, as it's among the very first times this new medicine is being tested in human volunteers. It helps researchers understand the drug before it can be studied in larger groups.
At a glance
What is this study about?
This study is an early-stage clinical trial, often called a Phase 1 study. This means it's one of the first times a new medicine, known as MK-4464, is being tested in people. The main aim of a Phase 1 study is to find out if a new drug is safe to use, what are the possible side effects, and how the body handles the drug.
In this particular study, participants will receive MK-4464 in two ways. Some will get MK-4464 on its own (that's called monotherapy), and others will get it combined with an already approved cancer drug called pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer. The researchers want to see how these treatments work both alone and together in people with advanced or metastatic solid tumours, which refers to cancers that have grown or spread from their original site.
The information gathered from this study is crucial. It helps scientists understand if MK-4464 could be a promising treatment for cancer in the future. If it proves safe and shows good signs, it could then move on to larger studies involving more people. This step-by-step process is how new medicines are developed and eventually become available to patients.
Key takeaways
- This is an early-stage study (Phase 1) testing a new drug for advanced cancers.
- It aims to find out if the new drug, MK-4464, is safe and how it works.
- MK-4464 will be tested alone and with another drug, pembrolizumab.
- It's for adults aged 18 and over with advanced or metastatic solid tumours.
- Participants will have regular visits and tests to monitor their health.
- You can stop participating at any time.
Who may be eligible?
This study is open to adults aged 18 years and older. There is no upper age limit, meaning older adults can also be considered.
To be eligible, you must have advanced or metastatic solid tumours. This means your cancer started in an organ and has either grown significantly or has spread to other parts of your body. Doctors will also check other health factors, like your general health and how well your organs are working, to make sure it's safe for you to take part.
There will be other specific health requirements and tests you'd need to meet. For example, previous treatments you've had, or certain health conditions, might affect whether you can join. The study team will review all your medical information carefully to see if this study is right for you.
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?
- Do you have a diagnosis of advanced or metastatic solid cancer?
- Are you generally well enough to take part in medical treatment?
- Are you able to attend regular clinic appointments and tests?
- Have you discussed this study with your current doctor?
What does participation involve?
If you decide to take part in this study, you would likely have a number of visits to the clinic. These visits are important for the study team to give you the medication, closely monitor your health, and perform various tests. These tests might include blood samples, urine samples, and physical examinations to see how you are responding to the treatment and to check for any side effects.
The medication, MK-4464 (and pembrolizumab if you are in that group), will be given according to a specific schedule decided by the researchers. The study will also involve regular check-ups to make sure you are still doing well. The total duration of your participation in the study, including treatment and follow-up, will be clearly explained to you by the study team before you agree to join.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What does 'advanced/metastatic solid tumours' mean?
It means the cancer started in an organ (like breast or lung) and has either grown a lot or spread to other parts of your body.
What is a 'Phase 1' study?
It's an early-stage study where a new drug is given to people for the first time to check if it's safe and how it works in the body.
What is MK-4464?
MK-4464 is a new experimental medicine being tested in this study. Its full purpose and effect are still being investigated.
What is pembrolizumab?
Pembrolizumab is an existing medicine that helps your body's immune system fight cancer. It's sometimes used in combination with new drugs.
Do I have to pay to be in the study?
No, medical studies usually cover the costs of the treatment and tests directly related to the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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