AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Advanced Solid Malignancies

This research study is looking at a new medicine called BMS-986523. It's for adults who have advanced solid tumours (cancers that form solid lumps in the body). This is an early-stage study, meaning it's one of the first times this medicine is being given to people. Doctors want to find out if it's safe to use, what side effects it might cause, and how much of the medicine stays in the body. They also want to see if it can help shrink tumours, both when given on its own and when combined with other cancer treatments. The main goal is to understand its safety and how the body processes it, but they're also looking for early signs of how well it works.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

09 Apr 2026

Advanced Solid Tumor Malignancies

What is this study about?

This study is a clinical trial, which means it's a carefully planned research project involving volunteers. The main purpose of this study is to learn more about a new experimental medicine called BMS-986523. This medicine is designed for people who have advanced solid tumours, which are cancers that have grown or spread in the body. These are early-stage trials (Phase 1 and Phase 2a), which means it's usually the first time doctors are giving this new medicine to people. This is a very important step to ensure any new medicine is safe before it can be widely used.

The main things the doctors want to understand are how safe this new medicine is and what side effects it might cause. They will carefully watch for any unwanted effects, including serious ones, and see if any side effects are strong enough to make someone stop taking the medicine. They will also look at how the body handles the medicine – how much gets into the blood, how long it stays there, and how quickly the body processes it. This helps them work out the best dose and how often to give it.

Beyond safety, the study also aims to see if BMS-986523 can help in treating cancer. Doctors will be checking to see if tumours shrink or stop growing, which they call an "overall response." They'll also measure how long any positive response lasts. This medicine will be tested both on its own and in combination with other existing anti-cancer treatments. This helps to see if it could be a useful new treatment option in the future.

Key takeaways

New medicine (BMS-986523) for advanced solid cancers.
Early-stage trial focused on safety and how the body handles the medicine.
Will also check if it shrinks tumours, alone or with other treatments.
Requires regular hospital visits for monitoring and tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you would generally need to be an adult, aged 18 or older. The study is open to both men and women.

The most important medical requirement is that you must have a type of advanced solid cancer. This means your cancer has either spread or is at a late stage. The doctors in the study will need to check your medical history and do some tests to make sure that taking part is suitable and safe for you.

There will also be other medical conditions or treatments you might be having that could mean you can't join the study. This is to protect your safety and make sure the study results are clear. Your doctor or the study team will be able to explain all the specific requirements in detail.

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 solid tumour cancer?
Are you able to attend regular hospital visits for study assessments?
Are you able to understand and agree to the study procedures?
Are you willing to follow the study treatment plan carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process. This involves medical checks and tests to make sure you fit all the requirements. Once you're accepted, you would receive the study medicine, BMS-986523, either on its own or with other cancer treatments, as decided by the study doctors. This medicine would be given to you in a way that's typical for the treatment type, which could be tablets or injections, for example.

You would need to attend regular clinic visits. During these visits, the study team would monitor your health carefully, check for any side effects, and perform tests like blood samples and scans to see how you're responding to the treatment and how the medicine is affecting your body. These visits would be more frequent at the beginning of the study. The total duration of your participation would depend on how your body responds to the treatment and the study plan, but it could last for some time, including a follow-up period after you stop taking the study medicine.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new, experimental treatment before it's widely available. While there's no guarantee the treatment will work for you, it could potentially help shrink your cancer or slow its growth. However, there are also risks. Because this is a new medicine, not all side effects are fully known, and you might experience unexpected or serious side effects. The study team will monitor you very closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical 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 kind of cancer is this study for?

This study is for adults who have advanced solid tumours, which are cancers that form a lump and have progressed or spread.

What does 'Phase 1/2a' mean for a medicine?

It means this is one of the first times this new medicine is being given to people. The main purpose is to check its safety, how the body handles it, and look for early signs of how well it works.

Will I get the new medicine by itself or with other treatments?

The study will test the new medicine, BMS-986523, both on its own and in combination with other common cancer treatments.

What are the main things doctors are looking for in this study?

The key goals are to understand how safe the new medicine is, what side effects it causes, how the body processes it, and to see if it helps shrink tumours or stop them from growing.

Do I have to keep taking the medicine if I don't feel well?

No, you can stop taking part in the study and discontinue the medicine at any time if you feel unwell or for any other reason. Your comfort and safety are a priority.