This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
Public ClinicalTrials.gov record NCT03449381. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 (Brigimadlin) in Patients With Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.
Study identification
- NCT ID
- NCT03449381
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 266 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 19, 2018
- Primary completion
- Nov 12, 2025
- Completion
- Nov 12, 2025
- Last update posted
- Mar 30, 2026
2018 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 9
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sarcoma Oncology Center | Santa Monica | California | 90403 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| Florida Cancer Specialists-Sarasota-61670 | Sarasota | Florida | 34232 | — |
| Norton Cancer Institute, Downtown | Louisville | Kentucky | 40202 | — |
| START Midwest | Grand Rapids | Michigan | 49546 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03449381, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03449381 live on ClinicalTrials.gov.