RecruitingPHASE1, PHASE2INTERVENTIONAL

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

This study is for adults aged 18 or over with certain types of HER2-positive cancer that has spread and can't be removed by surgery. These cancers include breast cancer, stomach cancer, and bowel cancer. We're looking at a new drug called zongertinib. Cancer cells with too much HER2 tend to grow more, and zongertinib aims to block this. The main goal is to find the safest and most effective dose of zongertinib, both on its own and when combined with other existing cancer treatments. We also want to see if this treatment can help shrink tumours after previous treatments haven't worked well. Participants will receive treatment in cycles, with doctors closely monitoring their health and any side effects.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Boehringer Ingelheim

Enrolment target

768

Start

03 Jun 2024

Estimated completion

08 Jan 2029

Metastatic Breast Cancer Metastatic Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Esophageal Adenocarcinoma Colorectal Cancer

What is this study about?

This study, called Beamion BCGC-1, is exploring a new treatment option for people living with different types of cancer that have spread to other parts of the body (this is called metastatic cancer). Specifically, it focuses on cancers that have a feature called "HER2-positive". A HER2-positive cancer means the cancer cells have too much of a protein called HER2 on their surface, which can make them grow and divide more quickly. The new drug being tested is called zongertinib, and it works by blocking this HER2 protein, hopefully slowing or stopping cancer growth.

The main aims of this study are twofold. Firstly, we want to find the safest and most effective dose of zongertinib. This is important because finding the right dose helps to manage potential side effects while still being strong enough to fight the cancer. We'll be testing zongertinib by itself and also in combination with several other established cancer treatments, such as trastuzumab deruxtecan and trastuzumab emtansine, among others. Secondly, once we've found suitable doses, we want to see if zongertinib, either alone or with other treatments, can help shrink the tumours or stop them from growing further in people whose cancer hasn't responded well to previous treatments.

This study is divided into two main parts. In the first part, different groups of participants will receive increasing doses of zongertinib to help identify the dose that is generally well-tolerated. In the second part, participants will be randomly assigned to different groups, each receiving a specific dose of zongertinib, either alone or with other treatments. This random assignment helps ensure the results are fair and reliable. Throughout the study, participants will have regular check-ups, and doctors will carefully monitor their health, measure tumour size using scans like CT or MRI, and record any side effects they experience. Your safety and well-being will be a top priority.

Key takeaways

This study tests a new drug, zongertinib, for HER2-positive cancers that have spread.
It aims to find the safest and most effective dose, alone and with other treatments.
Specifically targets breast, stomach, and bowel cancers that haven't responded to previous treatments.
Participants will undergo regular checks, scans, and blood tests to monitor their health and tumour changes.
You can stop participating at any time without affecting your normal care.

Who may be eligible?

This study is for adults aged 18 or older. To be considered, you must have a type of HER2-positive cancer that has spread to other parts of your body. This includes certain kinds of breast, stomach, and bowel cancer. It's important that your cancer cannot be removed by surgery.

Another key requirement is that your cancer has started to grow again or continued to spread despite having had previous cancer treatments. For most participants, this means your doctors will need to confirm that previous treatments aimed at HER2-positive cancers were not successful. You will need to provide samples of your cancer tissue for testing, either from previous biopsies or sometimes a new one.

In simple terms, if you're an adult with HER2-positive cancer that has spread, can't be operated on, and didn't respond well to earlier treatments, you might be suitable for this study. Your medical team can help determine if your specific situation fits all the criteria.

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 HER2-positive cancer that has spread?
Can your cancer not be removed with surgery?
Has your cancer continued to grow or spread despite previous treatments?
Are you willing to provide tumour tissue samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive treatment in cycles, meaning you'll get the study medicine for a period, then have a break, and then repeat. This could be zongertinib on its own or with other cancer treatments. Initially, in Part 1, you might be in a group that receives specific doses of zongertinib, which may change as researchers find the most suitable dose. In Part 2, you'll be placed into a group by chance to receive a particular treatment combination.

Throughout the study, you'll have regular visits to the study clinic. During these visits, doctors will closely check your health, ask about any new symptoms, and look for any unwanted effects the treatment might be causing. They will also take regular blood tests and likely perform scans, such as CT or MRI, to see how your tumour is responding to the treatment and whether it's shrinking or changing size. The frequency of these visits and scans will be explained in detail by the study team. The overall duration of your participation will depend on how you respond to the treatment and your health, but you can expect long-term monitoring.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new drug that could help control your cancer, especially if other treatments haven't worked. However, like all medications, zongertinib and the other treatments it's combined with can cause side effects. These could range from mild to severe, and the study doctors will explain all known risks. Your safety is crucial, and the medical team will carefully monitor you for any problems. It's vital to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (108)

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

Mayo Clinic-Arizona
Verified postcode
Phoenix, United States· Not yet recruiting
The Oncology Institute of Hope and Innovation
Verified postcode
Cerritos, United States· Recruiting
Ellison Medical Institute
Verified postcode
Los Angeles, United States· Not yet recruiting
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States· Recruiting
University of California Los Angeles
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California Irvine
Verified postcode
Orange, United States· Recruiting
Sharp Memorial Hospital
Verified postcode
San Diego, United States· Not yet recruiting
Yale University School of Medicine
Verified postcode
New Haven, United States· Recruiting
Mayo Clinic - Florida
Verified postcode
Jacksonville, United States· Not yet recruiting
H. Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States· Not yet recruiting
Orchard Healthcare Research Inc.- Skokie
Verified postcode
Skokie, United States· Not yet recruiting
Community Health Network
Verified postcode
Indianapolis, United States· Not yet recruiting

Common questions

What does HER2-positive mean?

HER2-positive means your cancer cells have too much of a protein called HER2, which helps them grow. Zongertinib aims to block this growth.

What kind of cancers are included in this study?

This study includes certain types of breast, stomach (including the gullet area), and bowel cancers that are HER2-positive and have spread.

What is the main goal of this study?

The main goals are to find the best dose of zongertinib, alone or with other drugs, that people can tolerate, and to see if it helps shrink tumours.

Will I definitely get the new drug?

Yes, if you join, you will receive zongertinib, either on its own or combined with other standard cancer treatments, depending on the study group you are in.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and this will not affect your ongoing medical care.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

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