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NCT05916313 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Glioma, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 12
- Study locations
NCT05916313: Active Phase 1 study of Glioma, sponsored by Boehringer Ingelheim.
NCT05916313 is a Phase 1 study of Glioma that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 18 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower). The trial reports 12 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05916313, a Phase 1 study of Glioma, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 12
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG BI 764532
Study Locations (12)
Other
- Salzburg Cancer Research Institute - Salzburg
- Universitätsklinikum Frankfurt - Frankfurt
- Klinikum der Universität München AÖR - München
- Universitätsklinikum Tübingen - Tübingen
- Erasmus Medisch Centrum-ROTTERDAM-50697 - Rotterdam
- Hospital del Mar - Barcelona
- Hospital Universitario 12 de Octubre - Madrid
- Cantonal Hospital of Aarau - Aarau
- University Hospital of Lausanne - Lausanne
- University Hosp. Zurich - Zurich
California
- University of California Irvine - Orange
Tennessee
- SCRI Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-01-30 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05916313 still lists
NCT05916313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which BI 764532 is the first listed.
NCT05916313 lists 12 locations in 3 states (Other, California, Tennessee).
Frequently Asked Questions
What is clinical trial NCT05916313 about?
NCT05916313 is a clinical study titled "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". 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 pe...
What is the current status of trial NCT05916313?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-01-30. Estimated completion is 2026-06-30.
What conditions does trial NCT05916313 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT05916313?
The interventions under investigation include: BI 764532 (DRUG).
Who is sponsoring clinical trial NCT05916313?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05916313 being conducted?
This trial has 12 study locations across California, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05916313's enrollment target sits among peer trials
18 72nd of 87 higher than 14 of 87 other Glioma trials
participants (enrollment target), bucketed by value
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