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NCT05446129 · ClinicalTrials.gov registry record · Phase 1
A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT05446129: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.
NCT05446129 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05446129, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in preparation of the upcoming surgery. The tested medicines in this study are antibodies that may help the immune system fight cancer. The purpose of this study is to find out how well people with early colorectal cancer can tolerate treatment with these medicines. The study also looks at whether the tumor changes. Participants are put into 2 groups. One group gets ezabenlimab and BI 765063. The other group gets pembrolizumab and BI 765063. All participants receive the study medicines as 2 subsequent infusions into a vein on a single day. Participants are in the study for about 4 months. During this time, they visit the study site about 5 times. The doctors check the health of the participants and note any health problems that could have been caused by ezabenlimab, pembrolizumab, or BI 765063. The doctors also check whether these health problems lead to a delay of the planned surgery.
Primary Outcome
Safety: A safety event was defined as any grade 3 or higher adverse events (AEs; according to National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) related to study treatments at any point within the follow-up period following the administration of study treatments. Feasibility (delay in surgery): A feasibility event or delay in surgery was defined as any treatment related AE leading to delay in surgery, which was scheduled to take place between 2 w
Interventions
- DRUG Pembrolizumab
- DRUG Ezabenlimab
- DRUG BI 765063
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-09-27 |
| Est. Completion | 2023-11-08 |
| Phase | Phase 1 |
Why NCT05446129 stopped before completion
NCT05446129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05446129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05446129 about?
NCT05446129 is a clinical study titled "A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery". This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in preparation of the upcoming surgery. The tested medicines in this study...
What is the current status of trial NCT05446129?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2022-09-27. Estimated completion is 2023-11-08.
What interventions are being tested in trial NCT05446129?
The interventions under investigation include: Pembrolizumab (DRUG), Ezabenlimab (DRUG), BI 765063 (DRUG).
Who is sponsoring clinical trial NCT05446129?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05446129's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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