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

Running, not enrolling · Phase 1

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT05916313

Run by

Boehringer Ingelheim

People needed

20

Starts

2024-01-30

Expected to finish

2027-09-30

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the first informed consent form (ICF1).
• Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
• Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
• Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment.
• Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review.
• Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria.
• Karnofsky performance score ≥70. Further inclusion criteria apply.

You may not qualify if…

• Previous treatment in this trial.
• Current enrolment in another investigational device or drug trial.
• Presence of extracranial metastatic or leptomeningeal disease.
• Previous treatment with therapies targeting DLL3.
• Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532.
• Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
• Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy.
• Further exclusion criteria apply.

Where it is running

• Hospital del Mar — Barcelona, Spain
• 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 Universitario 12 de Octubre — Madrid, Spain
• Cantonal Hospital of Aarau — Aarau, Switzerland
• University Hospital of Lausanne — Lausanne, Switzerland
• University Hosp. Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.