Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Randomized Study to Evaluate the Effect of Food on the Bioavailability of BMS-986158 in Participants with Advanced Solid Tumors.

This research study is for people who have advanced solid tumors, which are cancers that have grown or spread. The main goal is to understand how a new medicine, called BMS-986158, is absorbed by the body. Specifically, the study will check if eating food makes a difference to how much of the medicine gets into your system. This is a 'Phase 1' study, which means it's one of the first times this medicine is being tested in people. These early studies are very important for learning about a new medicine's safety and how it works in the body, which helps doctors decide if it's worth studying further. Participants will be aged 18 or older, and both men and women can take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

11 Dec 2023

Advanced Solid Tumors

What is this study about?

This research study is about a new medicine called BMS-986158, which is being investigated for people with advanced solid tumors. Solid tumors are a type of cancer that forms a lump, like breast cancer, lung cancer, or bowel cancer. 'Advanced' means the cancer has grown or spread in the body.

The main purpose of this study is to find out how well your body takes in the medicine BMS-986158 when you take it with food, compared to taking it without food. This is important information for doctors because it helps them understand if patients need to take the medicine at certain times, like before or after meals, to get the best effect. Think of it like some vitamins that work best with food, while others are better on an empty stomach.

This is an early-stage study, known as 'Phase 1'. This means it's one of the first times this specific medicine is being given to people. In Phase 1 studies, researchers focus on how safe the medicine is, what side effects it might cause, and how the body handles it. They also look at how much of the medicine stays in your system and for how long. The information gathered from this study will help decide if the medicine is safe and promising enough to move on to larger studies in the future.

Key takeaways

Tests a new medicine (BMS-986158) for advanced solid tumors.
Main goal: understands how the body absorbs the medicine with and without food.
This is an early-stage ('Phase 1') study focusing on safety and how the medicine works.
Open to adults aged 18 and over, both men and women.
Participation involves taking the medicine and regular clinic visits for health checks.

Who may be eligible?

To join this study, you need to be at least 18 years old, and there is no upper age limit. The study is open to both men and women.

You would be considered for this study if you have 'advanced solid tumors'. This means you have a type of cancer that forms a mass or lump in the body, and it has either grown or spread. A medical professional will be able to confirm if your specific cancer fits this description.

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 type of cancer called an 'advanced solid tumor'?
Are you able to attend regular clinic appointments?
Are you willing to take a new study medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, BMS-986158. The study involves taking the medicine in different ways, sometimes with food and sometimes without, so doctors can compare how your body reacts. You will have regular visits to the clinic, where the study team will carefully check your health. This will involve physical examinations, blood tests, and other checks to see how you are responding to the medicine and if you experience any side effects. The study team will explain all the visits and tests in detail.

Potential risks and benefits

Participating in a study like this might offer a chance to try a new medicine that isn't yet available. However, because this is an early-stage study, it's not certain if the medicine will help your cancer. There's also a possibility of experiencing side effects from the new medicine, some of which might not be known yet. The study team will carefully monitor you for any problems. Remember, you can always choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

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

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Unverified
Spain

Common questions

What is a 'solid tumor'?

A solid tumor is a growth of abnormal cells that forms a lump or mass, unlike blood cancers. Examples include breast, lung, or bowel cancer.

What does 'advanced' mean in relation to cancer?

Advanced cancer means the cancer has grown or spread from where it started to other parts of the body.

Will this medicine cure my cancer?

This is an early-stage study to understand the medicine better. It's not designed to cure cancer, but to see how it works and if it's safe enough for further research.

How long will I be in the study?

The study team will give you a detailed schedule of visits and the expected duration of your participation, including any follow-up appointments.

Do I have to pay to be in the study?

No, you don't have to pay to take part in clinical trials. The study will cover the costs of the research medicine and related tests.