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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1290-7234 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) | |
| 2022-501766-22-01 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 764532, dose escalation cohort | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 764532 | Drug | BI 764532 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose-limiting toxicity (DLT) during the entire treatment period | up to 26 months |
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Inclusion Criteria:
Exclusion Criteria:
Further exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| SCRI Oncology Partners |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| Nashville |
| Tennessee |
| 37203 |
| United States |
| Salzburg Cancer Research Institute | Salzburg | 5020 | Austria |
| Universitätsklinikum Frankfurt | Frankfurt | 60596 | Germany |
| Klinikum der Universität München AÖR | München | 81377 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Erasmus Medisch Centrum-ROTTERDAM-50697 | Rotterdam | 3015 GD | Netherlands |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Cantonal Hospital of Aarau | Aarau | CH-5001 | Switzerland |
| University Hospital of Lausanne | Lausanne | 1101 | Switzerland |
| University Hosp. Zurich | Zurich | 8901 | Switzerland |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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