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
NCT ID: NCT05916313
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2024-01-30
2026-03-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI 764532: Part A - Dose escalation cohort
Part B of the trial was removed via amendment/new protocol version from February 2025.
BI 764532
BI 764532
Interventions
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BI 764532
BI 764532
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 by central assessment.
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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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
University Hospital of Lausanne
Lausanne, , Switzerland
University Hosp. Zurich
Zurich, , Switzerland
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1290-7234
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-501766-22-01
Identifier Type: CTIS
Identifier Source: secondary_id
1438-0003
Identifier Type: -
Identifier Source: org_study_id