RecruitingPHASE1INTERVENTIONAL

A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

This study is testing a new drug called LY4050784 for people with advanced or metastatic solid cancers. These are cancers that have spread or are difficult to treat. The main goals are to find out if the drug is safe, what dose works best, and if it can help treat these cancers. We're also looking at people whose cancers have a specific genetic change called SMARCA4 (BRG1). The study drug might be given alone or with other cancer treatments. This research is for people who have already tried standard treatments, can't have them, or where there isn't a standard treatment available. The study is divided into different parts and is expected to last for about four years.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Eli Lilly and Company

Enrolment target

340

Start

19 Sep 2024

Estimated completion

01 Oct 2027

Metastatic Solid Tumor Advanced Solid Tumor Non-small Cell Lung Cancer SMARCA4-Deficient Tumor

What is this study about?

This research study is about a new medicine called LY4050784. It's being tested for adults who have advanced or metastatic solid cancers. Advanced means the cancer has grown, and metastatic means it has spread to other parts of the body. The main aim is to understand if this new drug is safe to use and if it can help treat these types of cancers. Doctors will be carefully watching for any side effects and how well the treatment works.

Sometimes, this new drug will be given on its own. Other times, it will be combined with standard cancer treatments like pembrolizumab, cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. The study is especially interested in cancers that have a particular change in a gene called SMARCA4 (sometimes called BRG1). This genetic change might be important in how the cancer grows and how it responds to treatment.

This study is for people who have already received standard cancer treatments that didn't work for them, or for those who can't have or don't want those standard treatments. It also applies if there aren't any other standard treatment options available for their type of cancer. By carefully studying this new drug, researchers hope to find new and more effective ways to treat difficult cancers.

Key takeaways

It's a study for advanced or spread solid cancers.
The new drug, LY4050784, is being tested for safety and effectiveness.
It focuses on cancers with a specific gene change called SMARCA4 (BRG1).
The treatment might be alone or with other standard cancer drugs.
It's for people who've tried other treatments or have limited options.

Who may be eligible?

To join this study, your cancer needs to be advanced or have spread. Importantly, your cancer cells must show a specific change in a gene called SMARCA4 (BRG1). This change will be checked by the study doctors after tests.

For some parts of the study, if you have non-small cell lung cancer (NSCLC), it needs to be locally advanced (has grown nearby) and not suitable for surgery or radiotherapy, or it has spread. If you have another type of cancer, it also needs to have this SMARCA4 gene change. You will also need to be generally well and able to carry out most of your daily activities.

Before joining, you will usually need to have already tried standard treatments for your cancer, or there might not be any standard treatment options left for you. In some specific situations within the study, you might not have had much treatment before.

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.

Do I have an advanced or metastatic (spread) solid cancer?
Has my cancer been tested for a SMARCA4 (BRG1) gene change?
Have I already tried standard cancer treatments, or are there no suitable treatments left?
Am I generally well and able to do most daily activities (ECOG 0-1)?
Am I at least 18 years old?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve regular visits to the clinic. At these visits, doctors will perform examinations, take blood and other samples, and ask you about your health and how you are feeling. You will receive the study drug, LY4050784, which might be given alone or with other cancer medicines, depending on which part of the study you are in. The type of medication you receive will be carefully explained to you.

Throughout the study, your health will be closely monitored. This includes checking for any side effects and how your cancer is responding to treatment. There will be specific tests to measure your cancer and see if the treatment is working. The study is designed to last for up to about four years, with regular check-ups and follow-up appointments during this time.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as gaining access to a new treatment that isn't yet widely available. This treatment might help shrink your cancer or slow its growth, especially if other treatments haven't worked or aren't available. However, there are also potential risks, as any new medicine can cause side effects. The study team will carefully monitor you for these and do their best to manage them. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

UCLA
Verified postcode
Santa Monica, United States· Recruiting
University of Colorado Health Hospital
Verified postcode
Aurora, United States· Recruiting
Sarah Cannon Research Institute at HealthOne
Verified postcode
Denver, United States· Recruiting
Florida Cancer Specialists ORLANDO/DDU
Verified postcode
Lake Mary, United States· Active not recruiting
University of Miami
Verified postcode
Miami, United States· Recruiting
University of Chicago
Verified postcode
New Lenox, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Dana-Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Columbia University Medical Center
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Ohio State University Hospital
Verified postcode
Columbus, United States· Recruiting
Sarah Cannon Research Institute
Verified postcode
Nashville, United States· Recruiting

Common questions

What kind of cancer is this study for?

This study is for people with advanced or metastatic solid cancers, especially those with a specific gene change called SMARCA4 (BRG1).

What is LY4050784?

LY4050784 is a new experimental drug being tested to see if it is safe and effective against certain types of cancer.

Will I take other medicines with LY4050784?

You might take LY4050784 on its own, or it could be combined with other standard cancer medicines, depending on the study plan.

How long will the study last?

The study is expected to last for up to about four years, including regular check-ups.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and your regular medical care will not be affected.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

lillytrials@lilly.com 1-317-615-4559 Official trial record

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