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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of BMS-986406 as Monotherapy and in Combination in Advanced Tumors

This study is an early-stage clinical trial (Phase 1) testing a new medicine called BMS-986406 for people with various advanced cancers. The main goals are to find out if the new medicine is safe for people, what doses are acceptable, and how it behaves in the body. Researchers will give BMS-986406 either on its own or together with other treatments to see how it works. This type of research is crucial because it helps scientists understand if a new medicine could be a promising treatment option in the future. It's the first time this specific medicine is being tested in humans, so it's a very early, but vital, step in medical research.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Bristol Myers Squibb International Corporation, Bristol Myers Squibb International Corporation
Enrolment target
27
Start
09 Jan 2024

What is this study about?

This clinical trial is designed to investigate a new medication, known as BMS-986406, in people who have advanced cancer. When we talk about "advanced cancer," it means cancer that has spread or is difficult to treat with standard therapies. The trial is a "Phase 1" study, which means it's one of the very first times this particular medicine is being given to humans. Early studies like this are essential because they help doctors learn about the medicine's safety and how it is processed by the body. This is a vital step before it can be tested in larger groups of people.

The study will look at BMS-986406 in two ways: first, on its own (as a "monotherapy"), and second, in combination with other existing treatments. By doing this, researchers hope to understand if the new medicine works better in certain situations or when paired with other medications. The ultimate goal is to see if BMS-986406 could eventually become a new and effective treatment option for people with advanced cancers.

It's important to remember that because this is a Phase 1 study, the main focus is on safety and understanding how the medicine works, rather than directly measuring how well it treats the cancer itself. However, findings from this kind of study are critical for deciding whether the medicine should move forward into larger studies that will look more closely at its potential to fight cancer.

Key takeaways

  • This is an early-stage study testing a new cancer medicine called BMS-986406.
  • It aims to find out if the medicine is safe and how it works in the body.
  • It's for adults (18+) with advanced cancers.
  • The medicine will be tested alone and with other treatments.
  • Your participation helps to advance cancer research.
  • You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with advanced cancer. Advanced cancer means that the cancer has spread or is difficult to treat with current standard options.

Before you can join, the study team will need to check some things about your health and your specific cancer. This is to make sure the study is a safe and appropriate choice for you. For example, they will look at your general health, how well your organs are working, and the types of treatments you may have had before.

Both men and women can take part in this study. The medical team will carefully review your full medical history and current health status against a detailed list of criteria to determine if you are a good fit for this particular research.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced cancer?
  3. Are you able to attend appointments regularly?
  4. Are you willing to follow a specific treatment plan?
  5. Have you discussed this study with your doctor?
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 several tests and checks to make sure the study is right for you. If you qualify, you would then start receiving the study medication, BMS-986406, either on its own or with other treatments. This medicine might be given in different ways, like an injection or a tablet.

You would have regular visits to the clinic, which might involve blood tests, scans, physical examinations, and answering questions about how you’re feeling. These visits are important for the doctors to monitor your health and how the medicine is affecting you. The number and frequency of these visits will vary depending on the stage of the study and your treatment plan.

Participation in clinical trials often involves a commitment over a period of time, which could range from several months to longer, including follow-up appointments after you stop taking the study medication. The study team will explain the full schedule of appointments and procedures to you in detail.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit could be access to a new medicine that isn’t yet widely available, which might help your condition, although this is not guaranteed, especially in an early-stage study focusing on safety. You would also be contributing to medical knowledge that could help others in the future. Potential risks include experiencing side effects from the new medicine or other treatments, which could be mild or more serious. The study team will monitor you closely for any side effects and will explain all known risks. It’s very important to remember that you are free 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
    Belgium

Common questions

What does 'advanced malignant tumors' mean?

It means cancers that have spread or are difficult to treat with standard medicines.

What is a 'Phase 1' study?

It's the first stage of testing a new medicine in people to check if it's safe and how it works.

Will this medicine cure my cancer?

This early study focuses on safety, not on whether the medicine will cure cancer. That will be explored in later studies.

How long would I need to be in the study?

The exact duration varies, but clinical trials often involve several months of regular visits and follow-up.

Can women take part in this study?

Yes, both men and women aged 18 and over can participate if they meet the other study criteria.

How to find out more

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

Discussion

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