Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
This study, called BT5528-100, is looking into a new medication called BT5528 for people with advanced solid tumors, including ovarian, lung, breast, and head and neck cancers, among others. These cancers are known to have a specific marker called EphA2. The research aims to find the safest and most effective dose of BT5528, both on its own and when given with another drug named nivolumab. We also want to understand any side effects and how well the treatment helps different types of cancer. This information will help us learn more about BT5528 and its potential as a treatment option.
At a glance
What is this study about?
This study is a clinical trial exploring a new potential treatment called BT5528 for advanced cancers. These are cancers that have spread or are difficult to treat with standard methods. The specific cancers being looked at in this study include ovarian cancer, bladder cancer, a type of lung cancer (non-small cell lung cancer), head and neck cancer, and a type of breast cancer called triple-negative breast cancer, along with stomach and upper gut cancers. Researchers are interested in these cancers because they often show high levels of a specific protein called EphA2, which BT5528 is designed to target.
The main goals of this study are important for developing new treatments. Firstly, the team wants to figure out the best and safest dose of BT5528 to give to patients, both when it's used alone and when it's combined with another approved cancer drug called nivolumab. Secondly, they want to keep a close eye on any side effects that people might experience. Lastly, and very importantly, they aim to see how effective BT5528 is at treating these different types of cancer. This means observing if it can slow down or shrink the cancer.
By taking part, individuals are helping doctors and scientists learn more about new ways to fight cancer. The information gathered from participants will be crucial for understanding if BT5528 could become a helpful treatment option in the future. The study is split into two parts: an early stage (Phase 1) to find the right dose and understand safety, and a later stage (Phase 2) to further test how well the cleared dose works.
Key takeaways
- This study is testing a new drug, BT5528, for advanced cancers with high EphA2.
- It aims to find the safest dose of BT5528, alone or with nivolumab.
- Researchers will also look at side effects and how well the treatment shrinks cancer.
- You need to have advanced solid tumors and meet certain health criteria to join.
- Participation involves regular clinic visits for treatment, tests, and monitoring.
- You can stop participating in the study at any time.
Who may be eligible?
To be considered for this study, you must be 18 years or older and generally in good health, able to manage daily activities without too much difficulty. You'll need to have a type of advanced solid tumor that researchers know often has high levels of a specific marker called EphA2. For most people, this means your cancer should have spread or come back despite previous treatments.
For women who could become pregnant, you'll need to have a negative pregnancy test and use effective contraception during the study. Men with female partners who could become pregnant also need to use effective birth control. You'll also need to have some of your tumor tissue (either existing samples or by having a small biopsy) checked for the EphA2 marker and other important details.
If you have ovarian cancer or certain other specific cancer types, you might not need to have your EphA2 levels confirmed before joining. For bladder cancer, you should have tried between one and three previous treatments. Overall, the study is for people who have exhausted other appropriate treatment options and are expected to live for at least 12 weeks.
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?
- Do you have an advanced solid tumour (like ovarian, lung, or breast cancer)?
- Have you generally tried other treatments for your cancer?
- Are you able to get to regular hospital appointments?
- Are you willing to provide a tumor sample (if needed)?
- Are you able to use effective contraception if you are a woman who could become pregnant, or a man with a female partner who could become pregnant?
What does participation involve?
Taking part in this study involves receiving a new drug called BT5528, which will be given once a week. Sometimes, it will be given on its own, and other times, it will be combined with another cancer drug called nivolumab. You'll have regular hospital visits for check-ups, blood tests, and scans to see how your body is reacting to the treatment and whether the cancer is responding. These visits will help the doctors understand the treatment's safety and effectiveness.
Throughout the study, you'll be monitored closely for any side effects. The total length of your participation will vary depending on how you respond to the treatment and the phase of the study you are in. Initially, the focus is on finding the right dose and understanding safety. Once a safe dose is found, the study will continue to see how well the treatment works. You will continue treatment for as long as it is helping you and is safe.
Potential risks and benefits
Locations (28)
- California Cancer Associates for Research and Excellence, Inc.Verified postcodeEncinitas, United States
- University of California - Irvine Medical CenterVerified postcodeOrange, United States
- Sarah Cannon Research Institute at HealthONEVerified postcodeDenver, United States
- Florida Cancer SpecialistsVerified postcodeSarasota, United States
- Barbara Ann Karmanos Cancer InstituteVerified postcodeDetroit, United States
- Comprehensive Cancer Centers of NevadaVerified postcodeLas Vegas, United States
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterVerified postcodeNew York, United States
- Stephenson Cancer Center (Oklahoma University)Verified postcodeOklahoma City, United States
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityVerified postcodePhiladelphia, United States
- Sarah Cannon and HCA Research InstituteVerified postcodeNashville, United States
- MD Anderson Cancer CenterVerified postcodeHouston, United States
- Virginia Cancer SpecialistsVerified postcodeFairfax, United States
Common questions
What is EphA2?
EphA2 is a protein found on the surface of some cancer cells. The study drug, BT5528, is designed to target this specific protein.
What is nivolumab?
Nivolumab is another cancer medicine that is already approved for use. In this study, it's being tested in combination with BT5528 to see if they work better together.
Will I receive the new drug BT5528, or a placebo (dummy treatment)?
Everyone in this study will receive BT5528, either on its own or with nivolumab. There is no placebo group in this trial.
How long will I be in the study?
The length of time you'll be in the study depends on how you respond to the treatment and whether the doctors decide it's safe and helpful to continue. It could last for several months or longer.
What kind of cancers are being studied?
We are studying advanced ovarian, bladder, non-small cell lung, head and neck, triple-negative breast, and gastric/upper gastrointestinal cancers.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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