Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase 1/2 Open-label Study of BMS-986466 in Combination with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Advanced Solid Tumors

This research study is looking at new ways to treat advanced cancers that have a particular genetic fault called KRAS G12C. These include some types of lung cancer (NSCLC) and bowel cancer (CRC). The study is testing a new drug called BMS-986466, either on its own or alongside other medicines like adagrasib and cetuximab. It's split into two main parts: an early phase to see if the new drug combinations are safe and what the best dose is, and a later phase to check if they can make tumours shrink. Researchers will carefully watch for any side effects and measure how well the treatments work. The main goal is to find safer and more effective ways to treat these specific cancers.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

23 Jan 2024

Oncology NSCLC and CRC

What is this study about?

Imagine your body's cells as tiny building blocks. Sometimes, these building blocks can change and grow out of control, leading to cancer. In some cancers, a specific genetic change or 'fault' happens in a gene called KRAS, particularly a type known as KRAS G12C. This study is for people who have advanced cancers, like certain lung cancers (named NSCLC) or bowel cancers (named CRC), that have this particular KRAS G12C fault.

The study is testing a new medicine, which for now is called BMS-986466. It's being investigated on its own or in combination with other existing cancer medicines, adagrasib and cetuximab. The idea is that these medicines might work together to target the cancer cells more effectively. Researchers want to understand two main things: first, how safe these new treatment combinations are and what side effects they might cause; second, if they can help to stop the cancer from growing or even make the tumours shrink. This kind of research is really important for finding new ways to fight cancer.

This study has two main parts. The first part (Phase 1) is about finding the right dose of the new medicines that is safe and tolerable for patients. The second part (Phase 2) then uses those safe doses to see how well the treatments work on a larger group of people. Doctors will be checking things like how long the cancer stays stable, how much the tumours shrink, and also monitoring the medicines in your body. It's a careful step-by-step process to learn as much as possible about these potential new treatments.

Key takeaways

This study evaluates new treatments for specific advanced lung and bowel cancers.
It focuses on cancers with a particular genetic change called KRAS G12C.
The primary aims are to assess safety and effectiveness in shrinking tumours.
Participants will receive new drug combinations and have regular medical checks.
It's an important step in finding new cancer therapies.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, your cancer must have a specific genetic change called KRAS G12C. This is a special type of cancer that doctors would have tested for already. The study is particularly looking for people with advanced non-small cell lung cancer (NSCLC) or advanced colorectal cancer (CRC).

There might be other health conditions or previous treatments that could mean someone isn't suitable for this study. These details would be discussed with your doctor to make sure the study is a safe and appropriate option 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?
Has your doctor told you that you have advanced lung cancer (NSCLC) or bowel cancer (CRC)?
Have your cancer tests shown that you have a KRAS G12C gene change?
Are you able to attend regular hospital or clinic appointments?
Are you willing to take study medicines as instructed and have regular tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'd be given a new medicine (BMS-986466) or a combination of medicines (BMS-986466 with adagrasib and/or cetuximab). These medicines are usually taken as tablets or given through a drip (IV infusion). You would have regular visits to the hospital or clinic to see the study team. During these visits, the doctors would carry out tests like blood samples, scans (such as CT or MRI scans) to check your cancer, and physical examinations to monitor your health and how you're responding to the treatment.

The study team would also ask you about any side effects you might be experiencing. The number of visits and the types of tests would vary depending on which part of the study you are in and how long you are on the treatment. The treatment would continue for as long as it benefits you and is safe, or until you choose to stop. There will also be follow-up appointments after you stop the treatment to monitor your health.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A possible benefit is that you might gain access to new treatments that aren't yet widely available, and these treatments might help control your cancer. However, there's no guarantee that the treatment will work for you, and it might not be better than standard treatments. On the other hand, the medicines might cause side effects, some of which could be serious. The research team will carefully explain all the known and potential risks before you decide to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Finland
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Unverified
France
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Unverified
Italy
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Unverified
Belgium

Common questions

What kind of cancer is this study for?

This study is for advanced types of lung cancer (NSCLC) and bowel cancer (CRC) that have a specific genetic change called KRAS G12C.

What are the new medicines being tested?

The main new medicine is called BMS-986466. It's being tested alone or with existing medicines like adagrasib and cetuximab.

What is the main goal of this study?

The main goals are to find out if the new medicine combinations are safe, what side effects they cause, and if they can shrink tumours.

How long will I be in the study if I join?

You would stay in the study as long as the treatment is helping you and is safe, or until you decide to stop. There will also be follow-up care.

Who is funding this research?

This study is being run by Bristol Myers Squibb (BMS), a pharmaceutical company.