Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to find a suitable dose of BI 765883 and to test whether it helps people with advanced pancreatic cancer when taken alone or together with chemotherapy

This research study is about a new medicine called BI 765883 for people who have advanced pancreatic cancer that has spread to other parts of their body. It's an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to find a safe and effective dose of BI 765883. Researchers will also be looking to see if this new medicine can help people with this type of cancer. They will test it in two ways: by itself and alongside the standard chemotherapy treatments that patients usually receive. This will help them understand if BI 765883 could be a useful new treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Enrolment target

Start

05 Aug 2024

Metastatic pancreatic ductal adenocarcinoma (mPDAC)

What is this study about?

This study is focused on a type of cancer called pancreatic ductal adenocarcinoma (often shortened to PDAC), specifically when it's advanced and has spread to other parts of the body. This is also known as metastatic pancreatic cancer. Researchers are testing a new potential medicine called BI 765883.

This is a 'Phase I' study, which means it's an early step in testing new medicines. It’s one of the very first times this particular medicine will be given to people. The main aim at this stage is to work out the safest and best dose of BI 765883. They will start with small doses and gradually increase them, carefully monitoring how people react.

Another important aim of this study is to see if BI 765883 can help people with advanced pancreatic cancer. They'll be looking to see if it can slow down the cancer's growth or shrink it. The medicine will be tested in two groups of people: some will receive BI 765883 on its own, and others will receive it along with the standard chemotherapy treatments they would normally have. This helps the researchers understand the medicine's effects in different situations.

Key takeaways

Tests a new medicine (BI 765883) for advanced pancreatic cancer.
Aims to find the safest and most effective dose.
Explores if the medicine works alone or with chemotherapy.
This is an early-stage (Phase I) study; it's one of the first times people will receive this medicine.
Open to adults aged 18 and over, both male and female.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Generally, participants will have advanced pancreatic cancer that has spread to other parts of the body. Doctors will look at your overall health and other specific medical conditions to make sure the study would be safe and appropriate for you. They will review all your medical information carefully.

It's important to remember that not everyone who is interested will be able to join. The research team needs to make sure that the study is a good fit for each individual and that all safety requirements are met.

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?
Have you been diagnosed with advanced pancreatic cancer that has spread?
Are you currently receiving treatment or considering treatment for this condition?
Are you able to attend regular hospital or clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, BI 765883. Depending on which group you are in, you might receive it alone or in combination with standard chemotherapy. You would have regular visits to the hospital or clinic for blood tests, physical examinations, and scans to monitor your health and how the treatment is working. The study team will explain exactly how often these visits would be. The total duration of your involvement could vary, but the study team will provide you with a clear timeline. There will also be follow-up calls or visits after your treatment period ends to continue checking on your health.

Potential risks and benefits

Participating in a study like this might give you access to a new medicine that isn't yet widely available, which could potentially help your condition. However, because this is a new medicine, there are also unknown risks and side effects that could occur. The study team will carefully monitor you for any problems. You will be fully informed about all known potential risks before you decide to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
France
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Unverified
Germany
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Unverified
Spain
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Unverified
Belgium

Common questions

What does 'advanced pancreatic cancer' mean?

It means the pancreatic cancer has spread from where it started to other parts of your body. This is also called metastatic cancer.

Is BI 765883 a new type of treatment?

Yes, it's a new medicine being tested for the first time in people, specifically for advanced pancreatic cancer.

Why is this called a 'Phase I' study?

Phase I means it's an early-stage study focusing on finding a safe dose, understanding how the new medicine works, and checking for any side effects.

Will I definitely get the new medicine if I join?

Yes, if you join this study, you will receive BI 765883, either by itself or along with other standard treatments like chemotherapy.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any point, and it will not affect the medical care you receive from your doctors.