Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Study BT7480-100 in Patients With Advanced Malignancies Associated With Nectin-4 Expression

This research study is looking into a new medication called BT7480, sometimes on its own and sometimes combined with an approved cancer drug called nivolumab. It's for people with advanced, widespread cancers (solid tumors) that have a particular feature called Nectin-4. The main goals are to figure out the safest and most effective dose of BT7480, both alone and in combination. We also want to understand any side effects, how the body handles the drug, and how it might help patients whose kidneys aren't working as well. This information will help us learn if this new treatment could be a useful option for future cancer care.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

BicycleTx Limited

Enrolment target

200

Start

02 Nov 2021

Estimated completion

01 Dec 2026

Advanced Solid Tumor

What is this study about?

This study is investigating a new treatment called BT7480 for people who have advanced cancer originating from solid organs. This type of cancer has spread or cannot be treated with standard methods, and it has a particular marker called Nectin-4. The treatment BT7480 is designed to target these cancer cells and boost the body's own immune system to fight them. This study will also try BT7480 alongside nivolumab, which is another medicine that helps the immune system fight cancer.

The study has a few key aims. First, the team wants to find the right amount, or 'dose,' of BT7480 that can be given safely, both on its own and when combined with nivolumab. They will carefully watch for any side effects to understand how the drug affects people. Second, they want to see how well BT7480 works at treating the cancer, and how the body takes in and gets rid of the medicine. Finally, they will look at how BT7480 affects people who might have some kidney problems, to make sure it's safe for them too.

By taking part, you would be helping doctors learn more about this new potential treatment. This kind of research is really important for developing new ways to fight cancer in the future. It's a phased study, meaning it starts with a small group to check for safety (Phase 1) and then expands to more people to look at how well it works (Phase 2), along with specific parts to study the combination and people with kidney concerns.

Key takeaways

This study is for people with advanced solid cancers that have a Nectin-4 marker.
It tests a new drug (BT7480) alone and with an existing drug (nivolumab).
Key goals are to find safe doses, understand side effects, and see if it helps treat cancer.
Participation involves regular hospital visits, receiving the study drugs, and close monitoring.
There are potential benefits and risks, similar to all new treatments.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you would generally need to have advanced cancer that started as a solid tumor, and that cancer must have a specific marker called Nectin-4. This marker is often found in somebladder, head and neck, lung, ovarian, breast, stomach, or gullet cancers. Your cancer should either not have responded to standard treatments, or your doctor believes existing treatments are not suitable or helpful for you. You should also be generally well enough to take part, meaning you can mostly look after yourself, and your important organs like your kidneys and blood are working reasonably well. Your doctor will need to see that your cancer can be measured to track any changes. You would also need to be expected to live for at least 12 more weeks and be willing to provide a sample of your tumor tissue.

There are also some reasons why you might not be able to join. For example, if you've recently had other cancer treatments like chemotherapy or immunotherapy, or if you've had certain immune-boosting treatments in the past. You also wouldn't be able to join if you have certain heart rhythm problems or severe, uncontrolled conditions like diabetes or high blood pressure. A history of certain autoimmune diseases (where your immune system attacks your body) would also prevent you from joining, but generally well-managed conditions like certain thyroid issues or hair loss are usually okay. If your cancer has spread to your brain and is causing severe symptoms, you might also not be able to take part.

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 solid cancer that has spread or can't be operated on?
Has my doctor confirmed that my cancer has the Nectin-4 marker?
Am I generally well, able to look after myself, and have my main body organs working ok?
Have I either run out of standard treatment options or are they not suitable for me right now?
Have I avoided recent chemotherapy or immunotherapy treatments (within the last few weeks)?
Do I have any serious, uncontrolled health issues like certain heart problems, diabetes, or high blood pressure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the hospital or clinic. These visits will involve various checks, including physical examinations, blood tests, and scans to monitor your health and the cancer. You will be given the study drug, BT7480, either on its own or together with nivolumab, usually once a week. The specific schedule and number of visits will depend on which part of the study you are in.

The study treatment will continue for as long as it is helping you and you are not experiencing severe side effects. Even after you stop the treatment, there will be follow-up visits or calls to check on your health. The total time you spend in the study will vary, but you should expect it to last for several months, potentially longer, depending on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical study carries potential benefits and certain risks. The main benefit is that you would be receiving a new treatment that is not yet widely available, which might help your cancer when standard treatments haven't. However, there's no guarantee that the treatment will work for you, and it might not improve your condition. Like all medicines, BT7480 and nivolumab can cause side effects. These could range from mild to severe and might be unknown at this stage. You will be closely monitored for any side effects to ensure your safety. It's important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

State University of Iowa
Verified postcode
Iowa City, United States
Columbia University Irving Medical Center
Verified postcode
New York, United States
University Hospitals Cleveland Medical Center
Verified postcode
Cleveland, United States
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States
MD Anderson Cancer Center
Verified postcode
Houston, United States
START Center for Cancer Care
Verified postcode
San Antonio, United States
Virginia Cancer Specialists
Verified postcode
Fairfax, United States
The Royal Marsden NHS Foundation Trust
Verified postcode
Sutton, United Kingdom
The Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom

Common questions

What is Nectin-4 and why does it matter for this study?

Nectin-4 is a specific protein marker found on the surface of some cancer cells. This study is looking at cancers that have this marker because the new drug, BT7480, is designed to target it.

What does 'advanced solid tumor' mean?

It means the cancer started in a solid organ (like the lung, breast, or bladder) and has either spread to other parts of the body or cannot be treated effectively by surgery.

What is the difference between Phase 1 and Phase 2?

Phase 1 studies mainly focus on finding the safest dose of a new drug and understanding its side effects. Phase 2 studies then look at how well the drug works in a larger group of people, while still monitoring safety.

Will I definitely receive the new drug BT7480?

Yes, if you join this study, you will receive BT7480, either on its own or in combination with nivolumab. This study does not use a placebo (dummy drug).

Can I stop taking part in the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without affecting your regular medical care. Your decision will be respected.