A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
This research study, called a Phase 1 trial, is looking into a new drug named LY4052031 for people who have advanced or spread cancers, such as bladder, breast, lung, and other solid tumors. The main goals are to find out if the drug is safe to use, how well people tolerate it, and to figure out the best dose. Researchers also want to see if the drug has a positive effect on the cancer. The drug works by targeting a specific protein often found on cancer cells. This study is split into two parts: one to find the right dose, and another to see how effective that dose is in different types of cancer. It's expected to run for about 4 years in total.
At a glance
What is this study about?
This study is about a new potential cancer treatment called LY4052031. It's what's known as a 'Phase 1' study, which is usually the first time a new drug is tested in people. The main aim is to check if the drug is safe, what side effects people might experience, and to find the strongest dose that can be given without causing too much harm. It's being offered to people whose cancer is advanced, meaning it has either spread to other parts of the body (metastatic) or is growing and hasn't responded to other treatments.
The drug itself is designed to work in a clever way: it's an 'antibody-drug conjugate'. Think of it like a guided missile. The 'antibody' part acts like the guidance system, finding and locking onto a specific target (a protein called nectin-4, which is often found on certain cancer cells). Once it's attached, the 'drug' part is delivered directly to the cancer cell, hopefully killing it while sparing healthy cells as much as possible. This targeted approach is a promising area in cancer research.
The study is being carried out in two main parts. The first part will test different doses of LY4052031 to find the safest and most effective amount. Once that 'optimal dose' is found, the second part of the study will involve more people with different types of advanced cancers to see how well the drug works and to gather more information on its safety. The overall study is expected to take around four years.
Key takeaways
- This is an early-stage (Phase 1) study for a new cancer drug called LY4052031.
- It aims to find a safe and effective dose, and see if the drug helps people with advanced cancers.
- The drug works by targeting specific proteins on cancer cells.
- Many types of advanced solid tumors are included, like bladder, breast, and lung cancer.
- Participation involves regular clinic visits for monitoring and assessments.
- It could offer early access to a new treatment, but potential risks are not fully known.
Who may be eligible?
To join this study, you would generally need to have certain advanced solid tumor cancers, such as bladder cancer, triple-negative breast cancer, non-small cell lung cancer, or several others listed. You must have already tried standard treatments for your cancer or there are no other standard treatments available for your disease. For some types of bladder cancer, there are also specific requirements about whether you've previously had a drug called enfortumab vedotin.
Your cancer also needs to be measurable in some way, so doctors can see if the treatment is working. Your general health and how well you can carry out daily activities will be assessed, usually needing to be quite good (doctors call this an 'ECOG performance status' of 0 or 1). Doctors will also need to be able to get a sample of your tumor tissue, either from a past biopsy or by doing a new one.
There are also reasons why someone might not be able to join, such as having other serious health conditions or certain medications that could interfere with the study drug. The research team will carefully review all your medical information to see if this study is suitable 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.
- Do I have one of the listed advanced solid cancers (e.g., bladder, breast, lung, etc.)?
- Have I already tried standard treatments for my cancer, or are there no standard options left?
- Is my general health good enough to participate (e.g., able to do most daily activities)?
- Can doctors get a sample of my tumor tissue (from a past biopsy or a new one)?
- Am I over 18 years old?
What does participation involve?
If you decide to take part in this study, you will receive the new drug, LY4052031. Because this is an early-stage study, there will be frequent visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the drug is affecting your cancer. These visits will also track any side effects you might experience. The exact number of visits and tests will depend on which part of the study you are in.
After you stop receiving the study drug, there will be a follow-up period where doctors will continue to monitor your health and collect information. The total length of your participation, including treatment and follow-up, could vary, but the entire study is expected to run for up to approximately 4 years.
Potential risks and benefits
Locations (33)
- City of Hope National Medical CenterVerified postcodeDuarte, United States· Recruiting
- UCLA Department of Medicine-Hematology/OncologyVerified postcodeLos Angeles, United States· Recruiting
- Sarah Cannon Research Institute at HealthOneVerified postcodeDenver, United States· Recruiting
- Florida Cancer Specialists and Research InstituteVerified postcodeSt. Petersburg, United States· Completed
- University of Chicago HospitalVerified postcodeChicago, United States· Recruiting
- IU Simon Cancer CenterVerified postcodeIndianapolis, United States· Recruiting
- Massachusetts General HospitalVerified postcodeBoston, United States· Recruiting
- START Midwest Cancer and Hematology Centers of W MichiganVerified postcodeGrand Rapids, United States· Recruiting
- Washington University School of Medicine in St. LouisVerified postcodeSt Louis, United States· Recruiting
- Icahn School of Medicine at Mount SinaiVerified postcodeNew York, United States· Recruiting
- Columbia University Irving Medical CenterVerified postcodeNew York, United States· Recruiting
- Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States· Recruiting
Common questions
What is LY4052031?
It's a new experimental drug being tested for different types of advanced cancers. It's designed to deliver treatment directly to cancer cells.
What does 'Phase 1' mean for a study?
Phase 1 means it's an early-stage study, mainly focused on checking if a new drug is safe, how the body handles it, and finding the right dose.
Which types of cancer are included?
This study is open to people with advanced bladder, triple-negative breast, non-small cell lung, oesophageal, pancreatic, ovarian, cervical, head and neck, and prostate cancers.
How long will the study last?
Your participation could vary, but the entire study is planned to last up to about 4 years, including treatment and follow-up.
Will I know if the drug is working?
The research team will regularly perform scans and tests to monitor your cancer and discuss the findings with you.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.