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Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Malignancies

This medical study is looking into a new treatment called BT8009, either by itself or combined with an existing drug called pembrolizumab. It's for people who have advanced cancers, including certain bladder, breast, lung, and ovarian cancers, that have specific features or have become difficult to treat with standard therapies. The main goals are to find a safe and effective dose of BT8009, understand how it behaves in the body, and see if it can help shrink tumours or stop them from growing. Researchers will also look at any side effects. This is a phased study, meaning it starts by checking safety and then expands to see how well the treatment works across different cancer types.

At a glance

What is this study about?

This study is a research project designed to test a new medicine called BT8009. It's being studied both on its own and in combination with another approved cancer drug called pembrolizumab. The new medicine is being looked at for people who have advanced solid tumours, which means cancers embedded in organs or tissues rather than blood cancers, that have either spread or are difficult to treat with other options. This particular study focuses on cancers that have a specific protein called Nectin-4 on their surface, or for certain patients with kidney problems.

The study has different parts. Initially, it's about finding the safest dose of BT8009 and understanding any side effects, both when it's given alone and when it's given with pembrolizumab. Once a suitable dose is found, the study will then look more closely at how well the treatment works against various advanced cancers, such as bladder, breast, non-small cell lung, and ovarian cancers. Researchers will also study how the body processes BT8009.

This kind of study is really important for developing new cancer treatments. By carefully testing new drugs, doctors can learn how they work, what doses are most effective, and how to manage any side effects. The ultimate aim is to find new and better ways to help people with advanced cancers that haven't responded well to other treatments.

Key takeaways

  • This study tests a new drug, BT8009, for advanced cancers.
  • It's for specific cancers with a protein called Nectin-4, or those difficult to treat.
  • The study aims to find a safe dose and see how well BT8009 works, alone or with pembrolizumab.
  • Participation involves regular visits, tests, and active treatment.
  • Potential benefits include access to new treatments; potential risks include side effects.
  • You can leave the study at any time without affecting your care.

Who may be eligible?

To join this study, you would generally need to have advanced cancer that has spread or is difficult to treat with standard approaches. Your doctors would need to confirm that your specific cancer has certain characteristics, such as the Nectin-4 protein on its cells for some parts of the study, or if it has progressed after previous treatment.

You would also need to be at least 18 years old and generally well enough to take part, with a life expectancy of at least 12 weeks. Your cancer would need to be measurable, meaning doctors can track its size. For some specific parts of the study, there are extra requirements depending on your cancer type and what treatments you've had before. For example, some parts are specifically for bladder cancer that has progressed after certain prior treatments.

It's important to remember that these are just general guidelines. The study team will review your full medical history and perform tests to confirm if you meet all the detailed criteria to ensure the study is safe and appropriate 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.

  1. Are you at least 18 years old?
  2. Do you have an advanced cancer that has spread or is difficult to treat?
  3. Has your doctor confirmed your cancer is 'measurable' (doctors can track its size)?
  4. Are you generally well enough to participate, with a life expectancy of at least 12 weeks?
  5. Have you discussed your previous cancer treatments with your doctor to see if they meet the study's requirements?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study treatment, either BT8009 alone or with pembrolizumab. The medication would typically be given through a drip (intravenous infusion). Depending on which part of the study you are in, you might receive treatment weekly, every two weeks, or on specific days within a three-week cycle. You would have regular visits to the clinic for assessments, including blood tests, scans (like CT or MRI) to check your cancer, and check-ups with the study doctors and nurses to monitor your health and any side effects. The total length of your participation would depend on how your cancer responds to the treatment and your general health, but it could involve many months of regular visits and follow-up after the treatment stops.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as receiving a new treatment that isn't yet widely available, which might help control your cancer where other treatments have not. However, there are also potential risks. The new drug, BT8009, may cause side effects, some of which could be serious or unexpected, as it is still being investigated. Your doctor and the study team will explain all known risks. Your safety and well-being will be closely monitored throughout the study, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (24)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Sarah Cannon Research Institute at HealthONE
    Verified postcode
    Denver, United States
  • Ocala Oncology Center
    Verified postcode
    Ocala, United States
  • Advent Health
    Verified postcode
    Orlando, United States
  • Icahn School of Medicine at Mount Sinai
    Verified postcode
    New York, United States
  • University Hospitals Cleveland Medical Center
    Verified postcode
    Cleveland, United States
  • Thomas Jefferson University, Sidney Kimmel Cancer Center
    Verified postcode
    Philadelphia, United States
  • Tennessee Oncology, PLLC
    Verified postcode
    Nashville, United States
  • Mary Crowley Cancer Research Center
    Verified postcode
    Dallas, United States
  • The University of Texas MD Anderson Cancer Center
    Verified postcode
    Houston, United States
  • University Health Network, Princess Margaret Cancer Centre
    Verified postcode
    Toronto, Canada
  • Institut Bergonie
    Verified postcode
    Bordeaux, France
  • Centre Leon Berard
    Verified postcode
    Lyon, France

Common questions

What is Nectin-4?

Nectin-4 is a protein found on the surface of some cancer cells. This study is focusing on cancers that have this protein, as the new drug BT8009 is designed to target it.

What does 'advanced solid tumour' mean?

An 'advanced solid tumour' means a cancer that started in an organ or tissue (not blood) and has either spread to other parts of the body or is no longer responding well to standard treatments.

What is pembrolizumab?

Pembrolizumab is an existing cancer treatment that helps your body's immune system fight cancer. In this study, it's being tested in combination with the new drug BT8009.

Will I get the new drug or a placebo?

In this specific study, you would receive the active study drug BT8009, either on its own or with pembrolizumab. There is no placebo involved in this trial.

How long will the study last for me?

The length of your involvement can vary. You would continue treatment as long as it is working for you and you are tolerating it well. You would also have follow-up visits after treatment stops.

How to find out more

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

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