A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors
This research study is looking at a new medicine called BLU-222 for adults with certain advanced cancers that have spread. This includes some types of breast cancer (HR+, HER2-negative, and those with a specific gene change called CCNE1 amplification), as well as ovarian, womb (endometrial), and stomach (gastric) cancers. We want to find the safest and most effective dose of BLU-222, both when given by itself and when combined with other existing cancer drugs like Kisqali, Carboplatin, or Fulvestrant. The first part of the study focuses on safety and understanding how the drug works in the body. The second part will then look at whether the medicine can shrink tumors or stop them from growing. The goal is to see if BLU-222 could be a helpful new treatment option.
At a glance
What is this study about?
This research study is investigating a new medication called BLU-222. It's designed for people who have certain types of cancer that are advanced, meaning they have spread to other parts of the body. The cancers being studied include some forms of breast cancer (specifically those that are hormone receptor-positive with a HER2-negative status, or those with a particular gene change called CCNE1 amplification), as well as ovarian, womb (endometrial), and stomach (gastric) cancers. The main aim is to understand if BLU-222 can be a new treatment option for these conditions.
The study has two main parts. The first part, called Phase 1, is about discovering the right amount of BLU-222 to give. Researchers will closely watch for any side effects and learn how the drug acts inside the body. This information helps them find a dose that is both safe and has the potential to be effective. Once a safe dose is found, the study moves to Phase 2, where more patients will receive the treatment.
In Phase 2, the focus shifts to how well BLU-222 works. Doctors will check if the drug can shrink tumors or stop them from growing, either when given alone or when combined with other established cancer medicines like Kisqali, Carboplatin, or Fulvestrant. Throughout both phases, patient safety is the top priority, with close monitoring of any changes in health. By conducting this research, scientists hope to bring forward a new drug that could help people with these challenging cancers.
Key takeaways
- This study tests a new drug, BLU-222, for advanced breast, ovarian, womb, and stomach cancers.
- It aims to find safe doses and see if BLU-222 can shrink tumors or stop their growth.
- BLU-222 might be given alone or with other established cancer treatments.
- Patient safety is closely monitored throughout the study.
- This research hopes to find new treatment options for challenging cancers.
Who may be eligible?
To be part of this study, you must be at least 18 years old. Both men and women can take part. You also need to have one of the specific advanced cancers that the study is looking at, such as certain types of breast cancer, ovarian cancer, womb (endometrial) cancer, or stomach (gastric) cancer.
The research team will need to check your general health to make sure you are well enough to participate. This will involve various medical tests and reviews of your health history. There may also be other specific medical criteria that need to be met, which the study doctor will discuss with you in detail.
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 advanced breast cancer, ovarian cancer, womb cancer, or stomach cancer?
- Are you able to attend regular clinic appointments and undergo medical tests?
- Are you willing to potentially take a new, experimental drug as part of the study?
- Are you prepared to discuss your full medical history with the study team?
What does participation involve?
If you join this study, you will receive the new medicine, BLU-222, potentially along with other common cancer drugs. You will have regular visits to the clinic for check-ups, blood tests, and scans to see how your body is reacting to the treatment and if your cancer is responding. These visits will be more frequent at the beginning of the study. You'll also be asked about any side effects you might be feeling. The length of time you take part will depend on how you respond to the treatment and your health, but you will have follow-up appointments even after active treatment finishes.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedSpain
Common questions
What is BLU-222?
BLU-222 is a new medicine being tested to treat advanced cancers. It's not yet approved for general use.
What does 'advanced solid tumors' mean?
This means cancers that started in solid organs (like breast, ovarian, or stomach) and have spread to other parts of the body.
Will I get BLU-222, or a different drug?
You will receive BLU-222. In some parts of the study, it will be given with other approved cancer medicines.
What are 'Phase 1' and 'Phase 2' of the study?
Phase 1 is about finding a safe dose and understanding how the drug works. Phase 2 tests if the drug is effective at treating the cancer.
How long will I be in the study if I join?
The length of your participation will vary depending on your individual response and health, and will include follow-up after treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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