Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an anti-human epidermal growth factor receptor 2 (anti-HER2) antibody-drug conjugate (ADC), in Previously Treated Subjects with HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer

This research study is testing a new medicine called BB-1701 for people with advanced breast cancer. This cancer can either have high levels of a protein called HER2 (HER2-positive) or low levels (HER2-low), and it has spread or cannot be removed by surgery. Participants in this study have already received other treatments for their cancer. The main goals are to find the safest and most effective dose of BB-1701. Researchers will check side effects and see if the new medicine helps shrink tumors or stop them from growing. This is a Phase 2 study, meaning the drug has already shown some promise in earlier tests.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Eisai Limited

Enrolment target

Start

24 Jul 2024

HER2 positive or HER2-low metastatic breast cancer

What is this study about?

This study is investigating a new medication called BB-1701 for people who have breast cancer that has spread to other parts of the body (metastatic) or cannot be removed through surgery. Importantly, this study is for those whose cancer has specific markers on its cells, known as HER2-positive or HER2-low. This means the cancer cells have certain amounts of a protein called HER2.

The medication, BB-1701, is a special type of drug designed to deliver a powerful medicine directly to cancer cells that have the HER2 marker, hopefully causing less harm to healthy cells. The study is split into two parts. In the first part, researchers are focusing on finding the best and safest dose of BB-1701, while also checking for any changes in the cancer. The second part will then use this optimal dose to further compare how well the drug works and its safety across more patients.

Researchers will be carefully monitoring how participants respond to the treatment. They will look at how many people see their tumors shrink or disappear, how long this improvement lasts, and generally how people feel and cope with the treatment. The aim is to gather enough information to understand if BB-1701 could be a helpful new treatment option for this type of breast cancer.

Key takeaways

New drug (BB-1701) for advanced HER2-positive or HER2-low breast cancer.
People in the study have already received other treatments.
Aims to find the best dose and check safety and effectiveness.
Regular health checks, blood tests, and scans will take place.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to be an adult, at least 18 years old. The study is open to both men and women.

The main condition for joining is having advanced breast cancer that is either HER2-positive or HER2-low. This means your cancer has certain identifiable markers. Also, your cancer must have spread to other parts of your body or be in a location where it cannot be removed by surgery. You must have also already received other treatments for your breast cancer.

There might be other specific health requirements or conditions that would prevent someone from joining, even if they meet these general criteria. These are checked by the study doctors to make sure the study is safe for everyone involved.

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 breast cancer that has spread (metastatic) or cannot be removed by surgery?
Has your doctor told you your breast cancer is HER2-positive or HER2-low?
Have you already had treatment for your breast cancer?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new study drug, BB-1701. The study team will regularly check your health through various assessments. This typically includes physical examinations, taking blood and urine samples for lab tests, checking your blood pressure and heart rate (vital signs), and performing heart rhythm checks (ECGs).

Doctors will also often measure your weight and assess your general well-being and ability to carry out daily activities. To see how the treatment is working, you will have regular scans to check the size of your tumors. The study involves ongoing visits and follow-ups to monitor your progress and any side effects. The total duration of your participation would depend on how you respond to the treatment and the study's design for follow-up.

Potential risks and benefits

There are potential benefits to joining a study like this. You would be among the first to receive a new treatment that might be effective for your condition, and your health will be closely monitored by a team of experts. However, there are also potential risks, as with any new medicine. The study drug might cause side effects, some of which could be serious or unexpected. Researchers will meticulously track all side effects. Taking part in research is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

—
Unverified
Spain
—
Unverified
Germany
—
Unverified
France

Common questions

What is HER2-positive or HER2-low breast cancer?

HER2 is a protein that can be found on the surface of breast cancer cells. If there's a lot of it (HER2-positive) or a small amount (HER2-low), it means the cancer cells might respond to specific treatments that target this protein.

What does 'unresectable or metastatic' mean?

Unresectable means the cancer cannot be completely removed by surgery. Metastatic means the cancer has spread from where it started to other parts of the body.

What is a 'Phase 2' study?

A Phase 2 study means the new drug has already been tested in a small number of people and has shown some promise. This phase aims to find the right dose and further assess its safety and how well it treats the condition in a larger group of patients.

Will I know if the drug is working for me?

The study team will regularly perform scans and tests to check the size of your tumors. They will discuss your progress and any changes with you during your appointments.

Will I have to pay to be in the study?

Generally, for clinical trials, the study drug and study-related tests are provided at no cost to you. However, you should confirm this with the study team.