RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

This research study is testing new combinations of medicines for adults who have advanced lung cancer or breast cancer. The main goals are to find out if these new medicine combinations are safe to use and how well people can tolerate them. We also want to understand how much of the medicine gets into participants' bodies and to see if there are any early signs that the treatments are helping to shrink or stop the cancer from growing. This is an early-stage study, which means we are exploring these new approaches to cancer treatment to learn more about their potential benefits and side effects. The study involves different groups of patients with specific types of lung or breast cancer.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

416

Start

04 Feb 2025

Estimated completion

26 Feb 2031

Lung Cancer Breast Cancer

What is this study about?

This study is investigating new treatments for advanced cancer, specifically certain types of lung cancer and breast cancer. When we talk about 'advanced' cancer, it means the cancer has spread from where it started or can no longer be removed by surgery. The main aim of this study is to explore new combinations of medicines to see if they can be helpful in treating these cancers.

Researchers want to understand several key things. Firstly, they need to check if the new medicine combinations are safe and if people can handle the side effects – this is called 'tolerability'. They also want to see how the medicines act in the body, such as how much of the drug gets into the bloodstream. Importantly, the study will look for early signs that these treatments are working against the cancer, for example, if they help to stop it from growing or shrink it.

This is a 'Phase 1' and 'Phase 2' study. Phase 1 studies are usually the first time a new medicine is given to people, and the main goal is safety. Phase 2 studies continue to look at safety but also start to gather more information about how well the treatment works. By doing this research, doctors hope to find better ways to treat advanced lung and breast cancer in the future.

Key takeaways

This study is testing new medicine combinations for advanced lung or breast cancer.
It aims to check if treatments are safe and show early signs of working.
Participation involves regular hospital visits for check-ups and monitoring.
There are specific requirements for different types of lung and breast cancer.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced lung cancer or breast cancer. To join, your cancer must have spread or be difficult to treat with surgery, and doctors need to be able to measure it. You should generally feel well and be able to do your daily activities with little trouble, and doctors expect you to live for at least three more months.

There are different groups in the study based on the specific type of lung or breast cancer you have. For example, some groups are for lung cancer with particular gene changes (called mutations), while others are for certain kinds of breast cancer, including a type known as 'triple-negative breast cancer.'

However, some people won't be able to join. This includes if you have a history of serious infections that keep coming back, or if you have severe heart problems. Also, people with certain types of lung cancer, like small cell lung cancer mixed with non-small cell lung cancer, or those with specific genetic changes in their lung cancer (if you're not in the specific group needing those changes), might not be eligible. Your doctor will carefully check all the details to see if this study is right 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 an adult aged 18 or over?
Do you have advanced lung or breast cancer?
Do you generally feel well and have a good level of day-to-day activity?
Has your doctor confirmed that your cancer meets the specific type required for the study?
Do you have any serious, recurring infections or severe heart problems? (If yes, you might not be eligible.)

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 new medicine combinations being tested. You will have regular visits to the hospital or clinic for check-ups, which will include blood tests, scans, and other medical assessments to see how you are responding to the treatment and to monitor for any side effects. The doctors will also track how much of the study drug is in your body.

The frequency and duration of these visits will vary depending on the specific treatment and stage of the study but will be explained fully before you join. You will be closely monitored throughout the treatment period. After you stop taking the study medicine, there will likely be follow-up appointments to continue checking on your health and any long-term effects. The total duration of your involvement, including treatment and follow-up, will be detailed by the study team.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might not benefit directly from this study, but the information gathered could help others with similar conditions in the future. The new medicine combinations may reduce the size of your tumour or control its growth, but there is no guarantee they will work for you. On the other hand, the medicines may cause side effects, some of which could be serious or unexpected. The research team will carefully monitor you for any side effects throughout the study. 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 medical care.

Locations (64)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Verified postcode
Miami, United States· Recruiting
Local Institution - 0125
Verified postcode
Maywood, United States· Not yet recruiting
Local Institution - 0065
Verified postcode
Iowa City, United States· Not yet recruiting
John Theurer Cancer Center at Hackensack University Medical Center
Verified postcode
Hackensack, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting
Local Institution - 0102
Verified postcode
Columbus, United States· Not yet recruiting
Local Institution - 0134
Verified postcode
Portland, United States· Not yet recruiting
Local Institution - 0052
Verified postcode
Portland, United States· Not yet recruiting
Local Institution - 0090
Verified postcode
Portland, United States· Not yet recruiting
Local Institution - 0014
Verified postcode
Pittsburgh, United States· Withdrawn
Local Institution - 0103
Verified postcode
Knoxville, United States· Not yet recruiting

Common questions

What is 'advanced' cancer?

Advanced cancer means that the cancer has spread from where it started or can't be fully removed with surgery. This study is for these types of cancers.

What are 'Phase 1' and 'Phase 2' studies?

Phase 1 studies mainly check if a new medicine is safe. Phase 2 studies continue to look at safety and start to see if the medicine works to treat the cancer.

Will I definitely get one of the new medicines?

Yes, if you join this study, you will receive one of the new medicine combinations being tested. There is no placebo group in this trial phase.

What kind of check-ups will I have?

You'll have regular visits, including blood tests, scans, and other medical assessments to check how you're doing and look for any side effects.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and it won't affect your regular medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

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