Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First in-Human, Consecutive-Cohort, Clinical Trial of BI 1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

This study is for adults with advanced solid cancers. It's an early-stage trial (Phase 1 and 2a) to understand a new medication called BI 1910. Researchers want to find out how safe BI 1910 is, what side effects it might cause, and the best dose to use. They will test it both by itself and in combination with another cancer drug called Pembrolizumab (Keytruda). The main goals are to monitor for any side effects, see how the body handles the drug, and look for early signs of how well it works. Participants will receive the study medications and have regular check-ups, blood tests, and scans to keep track of their health and how the treatment is affecting their cancer. This is a first step to see if BI 1910 could be a helpful new treatment option in the future.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Bioinvent International AB

Enrolment target

186

Start

14 Nov 2023

Advanced solid tumors

What is this study about?

This study, called BI 1910, is an early-stage clinical trial for people who have advanced solid cancers. 'Advanced' means the cancer has spread from where it started. The main purpose of this study is to explore a new treatment called BI 1910. This medication is a type of 'monoclonal antibody', which is a man-made protein designed to target specific things in the body, in this case, something called Tumor Necrosis Factor Receptor 2 (TNFR2) that is found on some cancer cells.

The study is split into two parts: Phase 1 and Phase 2a. In Phase 1, the focus is on safety. Researchers will start with a very low dose of BI 1910 and slowly increase it in different groups of people. This helps them figure out the highest dose that can be given without causing too many serious side effects, both when BI 1910 is given alone and when it's given with another anti-cancer drug called Pembrolizumab (also known as Keytruda).

Once a safe dose range is found, Phase 2a will begin. In this part, more people will receive the new treatment at the identified doses. The researchers will continue to closely monitor safety, but they will also start looking for early signs of how effective the treatment might be against the cancer. This involves carefully checking how the body absorbs and uses the drug, and observing any changes in the cancer itself. The aim is to gather enough information to see if this new treatment could be promising for future, larger studies.

Key takeaways

This study is testing a new cancer medicine called BI 1910.
It's for adults with advanced solid cancers.
The main goals are to check the drug's safety, side effects, and find the best dose.
Some people will get BI 1910 alone, others with another drug called Pembrolizumab.
Participation involves regular clinic visits, tests, and monitoring.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. There is no upper age limit for taking part.

This study is for both men and women. You would need to have an advanced solid tumour, which means a cancer that started in an organ and has spread. The medical team will check your specific cancer type and your overall health to make sure this study is right for you. They will review your medical history, current health, and any other treatments you might have had.

It's important to remember that not everyone with advanced solid cancer will be able to join. There will be specific health requirements and other criteria that the study doctors need to check carefully. They will discuss all of these with you in detail.

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 a diagnosis of an advanced solid cancer?
Are you able to travel to the study clinic for appointments?
Are you willing to have regular blood tests and physical exams?

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 drug, BI 1910, either on its own or in combination with Pembrolizumab (Keytruda). You might also be given other medications like paracetamol or allergy medicines (like diphenhydramine or clemastine) before your treatment to help prevent any potential reactions. These would be given through an IV drip or as tablets.

You would have regular visits to the clinic for treatment and check-ups. These visits will involve blood tests to monitor your health and how your body is reacting to the drug. The study team will also take your vital signs (like blood pressure and heart rate) and perform physical examinations. You will have regular scans to see how your cancer is responding to the treatment. The total duration of your participation would depend on how your body reacts to the treatment and how your cancer responds, but the team will explain the expected schedule in detail.

Potential risks and benefits

Participating in an early-stage study like this means that the potential benefits are not fully known. You might not directly benefit from the experimental treatment, but your involvement could help us learn more about new ways to treat cancer, which may help others in the future. As with any medication, there are potential risks and side effects. The study team will closely monitor you for any side effects, which could range from mild to serious, and they will explain what to look out for. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Denmark
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Unverified
Poland
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Unverified
Spain
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Unverified
Sweden
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Unverified
Germany

Common questions

What is BI 1910?

BI 1910 is a new medicine being tested. It's a type of treatment that targets specific parts of cancer cells.

What does 'advanced solid tumors' mean?

It means the cancer started in an organ (like the lung, breast, or colon) and has spread to other parts of the body.

Will I get the new drug or a dummy pill?

Everyone in this study will receive the new drug, BI 1910. There is no dummy pill (placebo) in this particular trial.

What is Pembrolizumab (Keytruda)?

Pembrolizumab, also known as Keytruda, is an existing cancer treatment that helps your immune system fight cancer cells. Some people in the study will get BI 1910 combined with this drug.

How long will I be on the study?

The length of time you'll be on the study depends on how your body responds to the treatment and how your cancer changes. The medical team will discuss this timeline with you.