Active not recruitingPHASE1INTERVENTIONAL

A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

This study is for adult patients diagnosed with a type of brain tumour called glioma, specifically when previous treatments haven't been successful. The main goal is to figure out the highest dose of a new experimental drug, BI 764532, that people can safely take. This drug is designed to help your body's immune system recognise and attack the cancer cells. Participants will receive BI 764532 through a drip. They will have regular check-ups at the study site, especially at the start, to make sure the treatment is safe and to monitor any side effects. If the treatment seems to be helping and is well-tolerated, participants can continue with it, with the number of visits depending on how they respond.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Boehringer Ingelheim

Enrolment target

Start

30 Jan 2024

Estimated completion

30 Sep 2027

Glioma

What is this study about?

This study, known as 1438-0003, is looking for adult patients who have a type of brain tumour called glioma. This particular study is for people whose tumour has a specific marker called DLL3, and for whom standard treatments haven't worked.

The main purpose of this study is to find the best and safest dose of a new medicine called BI 764532. This medicine is special because it acts like a bridge, connecting your body's immune cells (called T-cells) directly to the cancer cells. The idea is that by linking them together, your immune system will be better at finding and destroying the cancer. This is a very early-stage study, meaning it's one of the first times this drug is being tested in people.

Participants will receive BI 764532 through an intravenous drip (into a vein). Initially, they will need to stay at the study site so doctors can closely watch how they react to the treatment and ensure their safety. If the treatment is helping and isn't causing too many side effects, participants can continue with it. The number of times they need to visit the study site will depend on how their body responds to the medicine.

Key takeaways

This study is for adults with a specific type of brain tumour (glioma) where other treatments haven't worked.
It's testing a new drug (BI 764532) to see its safest and most effective dose.
The drug aims to help your own immune system fight the cancer.
You will receive the drug through a drip and have regular check-ups.
Your safety and any side effects will be closely monitored throughout the study.

Who may be eligible?

To be considered for this study, you must be 18 years old or older. You will need to provide your clear agreement to take part after understanding what the study involves. Doctors will need to confirm you have a brain tumour (glioma) that couldn't be controlled by previous treatments, and that your tumour shows a marker called DLL3. Your general health and ability to carry out daily activities will also be checked.

There are also some reasons why you might not be able to join. For example, if you've already been part of this specific trial or another drug trial at the same time. You also can't have cancer spread beyond your brain in certain ways, or have recently received certain types of cancer treatments or radiotherapy.

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 a primary progressive diffuse glioma?
Have previous treatments for your glioma not been successful?
Do doctors know that your tumour has the DLL3 marker?
Are you generally able to carry out your daily activities well?
Have you NOT had certain other cancer treatments very recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the new medicine, BI 764532, through a drip into your bloodstream. When you first start treatment, you'll need to stay at the study site so the doctors and nurses can carefully watch you for any reactions or side effects. You will have regular appointments at the study site. These visits will involve various health checks, blood tests, and scans to see how you are responding to the treatment and if you are experiencing any unwanted effects. The exact number of visits and how long they last will depend on how your body reacts to the medicine and if it's helping. If the treatment is beneficial and you tolerate it well, you can continue with it. You can withdraw from the study at any time.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. While this new treatment might help control your brain tumour, there's no guarantee it will work for everyone, as it's an early-stage study. There could be side effects from the drug, which doctors will closely monitor. You will be told about all known possible risks before you decide to join. It is very important to remember that you are free to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (12)

University of California Irvine
Verified postcode
Orange, United States
SCRI Oncology Partners
Verified postcode
Nashville, United States
Salzburg Cancer Research Institute
Verified postcode
Salzburg, Austria
Universitätsklinikum Frankfurt
Verified postcode
Frankfurt, Germany
Klinikum der Universität München AÖR
Verified postcode
München, Germany
Universitätsklinikum Tübingen
Verified postcode
Tübingen, Germany
Erasmus Medisch Centrum-ROTTERDAM-50697
Verified postcode
Rotterdam, Netherlands
Hospital del Mar
Verified postcode
Barcelona, Spain
Hospital Universitario 12 de Octubre
Verified postcode
Madrid, Spain
Cantonal Hospital of Aarau
Verified postcode
Aarau, Switzerland
University Hospital of Lausanne
Verified postcode
Lausanne, Switzerland
University Hosp. Zurich
Verified postcode
Zurich, Switzerland

Common questions

What is a glioma?

A glioma is a common type of tumour that starts in the brain or spinal cord. This study specifically focuses on certain types of these tumours.

What does DLL3 positive mean?

DLL3 is a specific marker that can be found on some cancer cells. For this study, your tumour must have this marker for you to be eligible.

What is BI 764532?

BI 764532 is a new experimental drug designed to help your body's immune system find and fight cancer cells that have the DLL3 marker.

Why are they looking for the 'highest dose I can tolerate'?

In early studies, doctors need to carefully find the dose that is most effective at fighting the cancer while also being safe and manageable for patients, with the fewest side effects.

Will I have to stay in the hospital?

Initially, when you start the treatment, you will need to stay at the study site or hospital so that doctors can closely watch you for any reactions or side effects to the new medicine.