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NCT03964233 · ClinicalTrials.gov registry record · Phase 1
A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab)
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT03964233 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 119 participants.
The verdict
NCT03964233, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
This study has 2 parts. The first part of the study is done. The first part was open to adults with different types of advanced cancer (solid tumors). The second part is open to people with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach, bladder or bile ducts. The participants get a combination of 2 medicines called brigimadlin (also called BI 907828) and ezabenlimab (also called BI 754091). Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer (immune checkpoint inhibitor). When the study started, some participants got a third medicine called BI 754111 in addition. Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111. The purpose of the first part of the study was to find out the highest dose of brigimadlin that the participants could tolerate in combination with ezabenlimab. This dose is used in the second part of the study. The purpose of the second part is to see whether the combination of brigimadlin with ezabenlimab is able to make tumors shrink. The participants are in the study as long as they benefit from treatment and can tolerate it. Ezabenlimab treatment is limited to 2 years. During this time, they get infusions of ezabenlimab, and take tablets with brigimadlin every 3 weeks. The doctors check how many participants have health problems during the study. The doctors also monitor the size of the tumor.
Interventions
- DRUG ezabenlimab
- DRUG BI 907828
- DRUG BI 754111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2026-02-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03964233
The ClinicalTrials.gov registry entry for NCT03964233 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ezabenlimab is the first listed.
NCT03964233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03964233 about?
NCT03964233 is a clinical study titled "A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab)". This study has 2 parts. The first part of the study is done. The first part was open to adults with different types of advanced cancer (solid tumors). The second part is open to people with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach, bladder or bile ducts....
What is the current status of trial NCT03964233?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2019-06-20. Estimated completion is 2026-02-06.
What interventions are being tested in trial NCT03964233?
The interventions under investigation include: ezabenlimab (DRUG), BI 907828 (DRUG), BI 754111 (DRUG).
Who is sponsoring clinical trial NCT03964233?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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