Active not recruitingPHASE1INTERVENTIONAL

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

This research study is looking for adults with advanced cancer (solid tumours) where previous treatments haven't worked or who have no other treatment choices. The main goal is to find the highest dose of a new medicine called BI 770371 that people can safely take, either on its own or alongside another medicine called ezabenlimab. Both BI 770371 and ezabenlimab are types of 'checkpoint inhibitors.' These medicines are designed to help your immune system recognise and fight cancer cells. This is the first time BI 770371 is being given to people. Participants will receive the treatment through a drip every three weeks and will be closely monitored for up to two years to see if the treatment helps and if they can tolerate it.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

17 May 2022

Estimated completion

30 Sep 2026

Solid Tumors

What is this study about?

This study is for people in the UK who have advanced cancer, specifically 'solid tumours.' This means the cancer has grown into a lump rather than being in the blood, like leukaemia. The study is open to patients who have already tried other cancer treatments that haven't worked, or for whom there are no other standard treatments available. It's a 'Phase 1' study, which means it's one of the first times this new medicine, BI 770371, is being tested in humans. The main aim is to carefully find the best and safest dose of BI 770371, both when given by itself and when combined with another medicine called ezabenlimab.

Key takeaways

This study is for advanced solid tumours when other treatments have failed.
It tests new medicines (BI 770371 and ezabenlimab) to help the immune system fight cancer.
The main goal is to find the safest and most effective dose.
Treatment involves regular infusions every three weeks.
Participation could last up to two years with close medical monitoring.
You can stop participating at any time.

Who may be eligible?

To be able to join this study, you must be 18 years old or older. You also need to have advanced solid tumour cancer that hasn't responded to previous treatments, or if there are no other standard treatments left for your type of cancer. Doctors will check that your cancer can be measured, and they'll also look at your general health and how active you are day-to-day. You should also be expected to live for at least three more months.

There are some reasons why you might not be able to join. For example, if you've had major surgery in the last 12 weeks, or if you're planning specific major surgery within the next year. You also can't have other active cancers (apart from very specific types, like treated skin cancer). Untreated brain tumours that have spread from your main cancer would also mean you couldn't take part. The doctors leading the study will need to make sure any side effects from your previous cancer treatments have mostly gone away before you can start this study.

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 solid tumour cancer that is advanced and hasn't fully responded to previous treatments?
Do you feel well enough to manage daily activities, even with your cancer?
Have any side effects from your previous cancer treatments mostly cleared up?
Have you *not* had major surgery recently (within 3 months) or are planning one soon (within 1 year)?
Do you *not* have another active cancer, or untreated cancer that has spread to your brain?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medicine, BI 770371 (either alone or with ezabenlimab), through a drip into your arm every three weeks. You'll have regular visits to the study clinic where doctors and nurses will monitor your health very closely. They will ask about any health problems you have and check how well you are tolerating the treatment. They will also regularly measure the size of your tumour to see if the treatment is working.

You could stay in the study for up to two years, as long as the treatment seems to be helping you and you are not having too many side effects. Throughout this time, you will continue to have regular check-ups and assessments at the study site. While the information doesn't specify follow-up after the two years, generally, study doctors continue to monitor participants for a period even after treatment ends.

Potential risks and benefits

The potential benefit of joining this study is that you would be getting access to a new medicine that could help your body fight cancer, especially if other treatments haven't worked for you. However, because these are new medicines, there are also risks. We don't fully know all the possible side effects, and some could be unpleasant or serious. The study team will monitor you very closely for any problems. It's very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Florida Cancer Specialists-Sarasota-61670
Verified postcode
Sarasota, United States
John Theurer Cancer Center
Verified postcode
Hackensack, United States
Centre Hospitalier de l'Universite de Montreal (CHUM)
Verified postcode
Montreal, Canada
National Cancer Center Hospital East
City only
Chiba, Kashiwa, Japan
National Cancer Center Hospital
Approximate
Tokyo, Chuo-ku, Japan

Common questions

What kind of cancer is this study for?

This study is for adults with advanced solid tumours, which means the cancer forms a lump and has spread or is hard to treat.

What are BI 770371 and ezabenlimab?

These are new medicines called 'checkpoint inhibitors' that aim to help your body's immune system fight cancer.

How will I receive the study medicine?

You will receive the study medicine through a small tube (drip) into your vein, much like a regular hospital drip, every three weeks.

How long will I be in the study?

You could be in the study for up to two years, as long as the treatment is helping you and you can tolerate it well.

What happens during study visits?

During your visits, doctors will check your general health, ask about any side effects, and monitor your tumour size to see how the treatment is working.