RecruitingPHASE1INTERVENTIONAL

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

This study, called MK-0472-001, is exploring a new medicine named MK-0472 for people with cancers that have spread or are advanced. Researchers want to understand if MK-0472 is an effective and safe treatment. Participants will receive MK-0472 either by itself or in combination with other medicines, pembrolizumab (also known as MK-3475) or MK-1084. The main goal is to check how well these treatments work in shrinking tumors, how the body handles them (tolerability), and if there are any side effects. This is a Phase 1 study, which means it's an early stage of testing new medications in people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

178

Start

06 Jul 2023

Estimated completion

12 Feb 2028

Metastatic Solid Tumors Advanced Solid Tumors

What is this study about?

This research study is looking into a new medication called MK-0472 for people who have advanced or metastatic solid tumors. 'Advanced' means the cancer is quite developed, and 'metastatic' means it has spread from where it started to other parts of the body. The main aim of the study is to see if MK-0472 can help to treat these cancers. Researchers will also be checking to see how safe the medicine is and how well people tolerate it.

Participants in the study will be split into different groups. Some will receive MK-0472 on its own. Others will receive MK-0472 alongside another known cancer drug called pembrolizumab, or with a different experimental drug called MK-1084. By testing MK-0472 in different ways, scientists hope to learn more about its potential. This is a "Phase 1" study, which is an early step in testing a new treatment. It helps doctors understand the right dose, safety, and initial effectiveness in a small group of people before moving to larger studies.

Understanding how new treatments like MK-0472 work is really important for developing better ways to fight cancer. While this is an early stage of research, the information gathered from studies like this helps to guide future cancer treatments. It's a key step in finding new options for people living with solid tumors that are advanced or have spread.

Key takeaways

This study evaluates a new cancer drug called MK-0472.
It's for people with advanced or spreading solid tumors.
MK-0472 is given alone or with pembrolizumab or MK-1084.
It's a Phase 1 study, focusing on safety and initial effectiveness.
Regular health checks and tests are part of participation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you generally need to be 18 years or older and have a solid tumor that has been confirmed by a doctor to be advanced or to have spread. For some parts of the study, your cancer needs to have specific genetic changes that doctors can look for.

There are also some requirements regarding your general health. For instance, if you have certain infections like Hepatitis B, Hepatitis C, or HIV, you might still be able to join if these conditions are well-managed and under control with treatment. This means your viral levels should be undetectable before you enrol in the study. Generally, you also need to have recovered from any serious side effects from previous cancer treatments more than four weeks ago.

Some things might prevent you from joining. For example, if you haven't recovered from side effects of previous treatments to a mild or better level, you might not be able to participate. Your study doctor will review all your medical information carefully to see if this study is suitable and safe 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 of age or older?
Do you have a solid tumor that has been confirmed to be advanced or has spread?
If you have Hepatitis B, C, or HIV, is it currently well-managed and under control with treatment?
Have you generally recovered to a mild level or better from side effects of any previous cancer treatments more than four weeks ago?
Has your doctor checked for specific genetic changes in your cancer (if required for certain study groups)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the study medications: MK-0472 on its own, or MK-0472 combined with pembrolizumab, or MK-0472 combined with MK-1084. These medications will be given to you at a clinic. You will have regular appointments where doctors and nurses will check your health, give you the medication, and perform various tests. These tests might include blood tests, scans (like CT scans), and physical exams to see how you are responding to the treatment and to monitor for any side effects. The exact number of visits, tests, and the length of your participation will depend on which treatment group you are in and how you respond. The study doctor and staff will explain all these details clearly before you make a decision.

Potential risks and benefits

Like all medical treatments, there may be potential benefits and potential risks to taking part in this study. The potential benefit is that the study treatment, MK-0472, either alone or with other medications, might help to control your advanced or metastatic cancer. However, as this is an early-stage study, we don't yet know if it will be effective for everyone, or how effective it will be. There is a chance the treatment may not help your cancer, or it could potentially cause side effects, some of which may be serious. The research team will explain all the known and potential risks to you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (25)

Northwestern Memorial Hospital ( Site 0002)
Verified postcode
Chicago, United States· Recruiting
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Verified postcode
Louisville, United States· Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)
Verified postcode
Hackensack, United States· Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0005)
Verified postcode
New Brunswick, United States· Recruiting
Princess Margaret Cancer Centre ( Site 0101)
Verified postcode
Toronto, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)
Verified postcode
Montreal, Canada· Recruiting
Jewish General Hospital ( Site 0104)
Verified postcode
Montreal, Canada· Recruiting
Centro de Estudios Clínicos SAGA ( Site 0701)
Verified postcode
Santiago, Chile· Recruiting
Fundacion Arturo Lopez Perez ( Site 0700)
Verified postcode
Santiago, Chile· Recruiting
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)
Verified postcode
Santiago, Chile· Recruiting
Bradfordhill ( Site 0702)
Verified postcode
Santiago, Chile· Recruiting
Rambam Health Care Campus ( Site 0304)
Verified postcode
Haifa, Israel· Recruiting

Common questions

What is MK-0472?

MK-0472 is a new investigational medication being studied for people with advanced or spreading cancers.

What does 'Phase 1' mean?

Phase 1 means this is an early stage of testing a new drug. It focuses on finding a safe dose, understanding side effects, and seeing how the body handles the medicine.

Will I get only MK-0472?

You might get MK-0472 on its own, or it might be combined with other medicines called pembrolizumab or MK-1084, depending on the study group.

Can I join if I've had other treatments?

Yes, many participants in cancer studies have had previous treatments. Your doctor will check if you meet specific recovery criteria from those treatments.

How long will the study last?

The exact length of your participation will vary. The study team will explain the expected duration and follow-up plan for you.

How to find out more

Toll Free Number

trialsites@msd.com 1-888-577-8839 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.