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NCT02952248 · ClinicalTrials.gov registry record · Phase 1
A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
NCT02952248: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT02952248 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 110 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02952248, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
Study Summary
The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advanced solid malignancies. Safety and tolerability will be evaluated by monitoring the occurrence of adverse events (AEs), serious AEs (SAE), and laboratory parameter abnormalities, as well as changes to vital signs. Secondary objectives are the determination of the PK profile of BI 754091 after single and multiple doses of BI 754091, and the preliminary assessment of antitumour activity. In the dose-expansion part of the trial, the main objectives are to further assess the safety, efficacy, PK profile, and biomarkers of BI 754091 in tumours with specific tumour types and/or genetic mutations at the RP2D.
Primary Outcome
Number of participants experiencing dose-limiting toxicities (DLTs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 / 5.0 observed in the first cycle (3 weeks) in order to meet the objective of assessment of the maximum tolerated dose (MTD) of ezabenlimab.
Interventions
- DRUG BI 754091
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 1 |
What the finished NCT02952248 record still lists
NCT02952248 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% higher).
The record links to 0 conditions, and to 1 intervention - of which BI 754091 is the first listed.
NCT02952248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02952248 about?
NCT02952248 is a clinical study titled "A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours". The main objective of the dose-escalation part of the trial is to determine the safety and tolerability, and to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose (RP2D) of BI 754091 on the basis of patients with dose-limiting toxicities (DLTs) in patients with selected advance...
What is the current status of trial NCT02952248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2016-11-21. Estimated completion is 2023-08-01.
What interventions are being tested in trial NCT02952248?
The interventions under investigation include: BI 754091 (DRUG).
Who is sponsoring clinical trial NCT02952248?
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 NCT02952248's enrollment target sits among peer trials
110 514th of 2000 higher than 1,479 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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