NCT05916313Recruiting

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

Summary

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.

Inclusion criteria

1. 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). 2. 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. 3. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies. 4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression. 5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review. 6. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria. 7. Karnofsky performance score ≥70. Further inclusion criteria apply.

Exclusion criteria

1. Previous treatment in this trial. 2. Current enrolment in another investigational device or drug trial. 3. Presence of extracranial metastatic or leptomeningeal disease. 4. Previous treatment with therapies targeting DLL3. 5. 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. 6. 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. 7. 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.

Contacts

The trial team's contact details are shown on request.

See the official trial record

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Countries: Switzerland, Germany, Austria, United States, Netherlands, Spain
Sponsor: Boehringer Ingelheim(Industry)
Protocol no.: 1438-0003
Conditions: Glioma
Interventions: Drug

Treatments studied

BI 764532

Locations · 10

Aarau, SwitzerlandCantonal Hospital of AarauRecruiting at this site
Lausanne, SwitzerlandUniversity Hospital of LausanneRecruiting at this site
Zurich, SwitzerlandUniversity Hosp. ZurichRecruiting at this site
Frankfurt, GermanyUniversitätsklinikum FrankfurtRecruiting at this site
Salzburg, AustriaSalzburg Cancer Research InstituteRecruiting at this site
Orange, United StatesUniversity of California IrvineRecruiting at this site
Nashville, United StatesSCRI Oncology PartnersRecruiting at this site
Rotterdam, NetherlandsErasmus Medisch Centrum-ROTTERDAM-50697Recruiting at this site
Barcelona, SpainHospital del MarRecruiting at this site
Madrid, SpainHospital Universitario 12 de OctubreRecruiting at this site

In total, worldwide, 10 of the 12 sites listed in the registry are recruiting; the other 2 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 27, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

U1111-1290-7234 · other registry
2022-501766-22-01 · CTIS number

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.