Phase
Condition
Brain Cancer
Neurofibromatosis
Cancer
Treatment
BI 764532
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants ≥18 years old and at least at the legal age of consentin countries where it is greater than 18 years at the time of signature of the firstinformed consent form (ICF1).
Signed and dated written informed consent (ICF1 and ICF2) in accordance withInternational Council for Harmonisation-Good clinical practice (ICH-GCP) and locallegislation prior to admission to the trial.
Patients with histologically confirmed primary progressive diffuse glioma who havefailed standard of care therapies.
Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by centralassessment.
Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) onarchived tumour tissue according to central pathology review.
Documented unequivocal progression after radiotherapy and/or chemotherapy withmeasurable disease by response assessment in neuro-oncology (RANO) criteria.
Karnofsky performance score ≥70. Further inclusion criteria apply.
Exclusion
Exclusion Criteria:
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 firstadministration of BI 764532.
Recent anti-cancer therapy: treatment with any other anticancer drug within 21 daysor within 5 half-life periods (whichever is shorter) prior to first administrationof BI 764532.
Radiotherapy within the 3 months prior to the diagnosis of progression; unlesstumour progression is clearly outside the radiation field or tumour progression isunequivocally proven by surgery/biopsy.
Further exclusion criteria apply.
Study Design
Connect with a study center
Salzburg Cancer Research Institute
Salzburg, 5020
AustriaActive - Recruiting
Universitätsklinikum Frankfurt
Frankfurt am Main, 60528
GermanyActive - Recruiting
Klinikum der Universität München AÖR
München, 81377
GermanyActive - Recruiting
Universitätsklinikum Tübingen
Tübingen, 72076
GermanySite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Cantonal Hospital of Aarau
Aarau, CH-5001
SwitzerlandActive - Recruiting
University Hospital of Lausanne
Lausanne, 1101
SwitzerlandActive - Recruiting
University Hosp. Zurich
Zurich, 8901
SwitzerlandActive - Recruiting
University Hosp. Zurich, Dept. of Neurology, Stroke Center
Zurich, 8091
SwitzerlandSite Not Available
University of California Irvine
Orange, California 92868
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
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