This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful. The purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3/CD3 bispecific). This may help the immune system fight cancer. Participants get BI 764532 infusions into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
BI 764532
University of California Irvine
Orange, California, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Salzburg Cancer Research Institute
Salzburg, Austria
Universitätsklinikum Frankfurt
Frankfurt, Germany
Klinikum der Universität München AÖR
München, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, Netherlands
Hospital del Mar
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Cantonal Hospital of Aarau
Aarau, Switzerland
...and 2 more locations
Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period
Time frame: up to 4 weeks
Occurrence of dose-limiting toxicity (DLT) during the entire treatment period
Time frame: up to 26 months
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