A study to investigate how well BI 764532, at different doses, is tolerated by individuals with DLL3-positive brain tumors
Summary description of the study
This study has two parts, Part A (dose escalation) and Part B (dose expansion). This information and consent form is for study participants who are participating in Part A (dose escalation).
Part A of this study aims to determine how well different doses of the investigational drug BI 764532 are tolerated by patients with a brain tumor that is positive for a tumor marker called "DLL3" and has progressed after treatment with standard therapies.
Part A of this study will also evaluate how effective the treatment is based on clinical response (whether it can treat your tumor or prevent it from worsening), as well as based on various biomarkers (characteristics of the body that can be measured) in the blood and tumor tissue. It will also test how quickly or slowly the investigational drug is processed by your body and eliminated.
The collected data were used to determine the recommended dose for Part B (dose expansion) of the study.
In Part B (dose expansion), it will now be further evaluated how well the recommended dose indicated in Part A (dose escalation) is tolerated. As in Part A of this study, Part B will also evaluate the effectiveness of the treatment based on clinical response (whether it can treat your tumor or prevent worsening) as well as based on various biomarkers (body characteristics that can be measured) in the blood and tumor tissue. It will also test how quickly or slowly the investigational drug is processed by your body and eliminated.
(BASEC)
Intervention under investigation
In this study, we want to find out what effect the investigational drug BI 764532 has on patients with tumor tissue confirmed as DLL3-positive.
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Disease under investigation
DLL3-positive brain tumors
(BASEC)
• Age: 18 years and older
• Confirmed diagnosis of a brain tumor with evidence of the biomarker Delta-like Protein 3 (DLL3)
• Availability of tumor tissue for analysis of DLL3 protein expression and IDH 1/2 mutation
• Patients with histologically confirmed primary progressive diffuse gliomas for whom standard therapies have failed
• Willingness to undergo all required study procedures
(BASEC)
Exclusion criteria
• Previous treatment with therapies targeting DLL3
• Patients have been diagnosed with an immunodeficiency or are taking any medications for the treatment of immunodeficiency within 7 days prior to the first dose of BI 764532 (especially systemic corticosteroids at a dose greater than 2.5 mg of dexamethasone per day or something comparable).
• Radiation therapy within the last three months prior to the diagnosis of disease progression, unless the tumor progression is clearly outside the radiation field or is clearly demonstrated by surgery/biopsy.
• Patients with implanted pacemakers, defibrillators, or other implanted metallic or electronic devices, as these would interfere with MRI imaging.
(BASEC)
Trial sites
Aarau, Lausanne, Zurich
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Sponsor
Boehringer Ingelheim International GmbH
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Contact
Contact Person Switzerland
Prof. Patrick Roth
+41 44 255 55 21
patrick.roth@clutterusz.chUniversitätsspital Zürich
(BASEC)
Scientific Information
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Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
29.09.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Eine unverblindete, multizentrische Phase-Ib-Dosiseskalationsstudie zu BI 764532, verabreicht als Monotherapie in wiederholten intravenösen Infusionen an Patienten mit DLL3-exprimierenden Gliomen (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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