A study to test different doses of BI 765049 in people with advanced cancer of the colon, rectum, stomach, or pancreas
This clinical trial is looking at an experimental drug called BI 765049 in adults with advanced digestive cancers, including cancer of the bowel (colon or rectum), stomach, or pancreas. It is a Phase 1 study, which is the first step in testing a new treatment in humans. The main goal is to find the safest dose of BI 765049 with the fewest side effects. Researchers will start with smaller doses and slowly increase them as they check how well patients tolerate the medicine. They will also look closely at how the drug behaves inside the body and whether it helps control cancer growth. Taking part is voluntary and involves regular hospital visits for treatment, blood tests, and health checks. This study may suit people whose cancer has spread or is no longer responding well to standard NHS treatments.
At a glance
What is this study about?
When cancer in the colon, rectum, stomach, or pancreas becomes advanced, it may spread to other parts of the body or stop responding to standard treatments like chemotherapy. When this happens, doctors look for new ways to target cancer cells. This study is testing an experimental medicine called BI 765049 to see if it could become a helpful new option in the future.
Because this is an early-stage study, known as a Phase 1 trial, the main aim is safety rather than proving how well the medicine works. Researchers need to discover the best dose to give people. They do this by giving small amounts to the first group of patients, then gradually increasing the dose for new groups if it proves safe. Throughout the trial, doctors carefully track any side effects.
Finding the right dose is essential before a medicine can move on to larger trials. Even though this study is focused on safety, doctors will also carefully monitor the tumours to see if BI 765049 can help slow down, stop, or shrink the cancer.
Key takeaways
- Tests an experimental drug called BI 765049 for advanced bowel, stomach, and pancreatic cancers.
- Mainly focuses on finding the safest and most effective dose for future use.
- Open to adults aged 18 and older whose cancer has progressed or spread.
- Requires regular clinic visits for treatment, blood tests, and scans.
- Participation is entirely voluntary, and you can stop at any time without losing NHS care.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with advanced cancer of the colon, rectum, stomach, or pancreas. Advanced cancer usually means the disease has grown locally or spread to other parts of the body, and standard treatments may no longer be keeping it under control.
To join, participants generally need to be well enough to carry out daily tasks and look after themselves, as travel to the hospital and taking part in medical checks can take energy. Their liver, kidneys, and bone marrow also need to be working reasonably well to safely handle the new medicine.
People might not be able to join if they have certain serious medical conditions, uncontrolled infections, or if they are taking other medicines that could interfere with the study drug. A trial doctor will carefully review your full medical history and test results to make sure it is safe for you 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.
- I am aged 18 or older.
- I have been diagnosed with advanced cancer of the colon, rectum, stomach, or pancreas.
- My cancer is advanced, spreading, or no longer responding to standard treatments.
- I feel well enough to manage my daily activities and travel to hospital appointments.
- I am willing to undergo regular blood tests, heart checks, and scans.
What does participation involve?
Taking part in this study means visiting a specialist hospital clinic regularly. During your visits, you will receive BI 765049 and have detailed health checks. These include regular blood tests, heart checks (such as ECGs), and body scans (such as CT or MRI scans) to track how your body and your tumour respond.
You will be asked to report any symptoms or side effects you notice. The study usually lasts for as long as the treatment is helping you and the side effects remain manageable. After finishing the medication, you will have follow-up visits or telephone check-ins so the team can monitor your recovery and ongoing health.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is one of the earliest steps in testing a new medicine in people. Its main goal is to find out if the drug is safe, what the best dose is, and what side effects it causes.
Will I have to pay for the study treatment?
No, you do not pay for the trial medicine. In many trials, help with travel expenses to and from hospital appointments is also available.
Can I carry on taking my normal medicines?
It depends on the medicine. The trial team will review everything you take, including vitamins and over-the-counter tablets, to make sure they do not interact with the study drug.
Will I definitely receive the new drug?
Yes. Early-stage dose-finding trials like this do not usually use a dummy drug (placebo). Every participant receives a dose of the active trial medicine.
What happens if I decide to leave the trial?
You are free to leave the trial at any point. Your decision will not affect your relationship with your medical team or the quality of your regular NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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