Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
Public ClinicalTrials.gov record NCT06058793. 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
Brightline-4: A Phase III Open-label, Single-arm, Multi-center Study to Assess the Safety and Efficacy of Brigimadlin (BI 907828) Treatment in Patients With Treatment-naïve or Pre-treated Advanced Dedifferentiated Liposarcoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out whether a medicine called brigimadlin (BI 907828) is tolerated by and helps people with DDLPS. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check participants' health and take note of any unwanted effects. The doctors also regularly check tumour size.
Study identification
- NCT ID
- NCT06058793
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 138 participants
Conditions and interventions
Conditions
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
- Dec 13, 2023 (Actual)
- Primary completion
- Dec 12, 2025 (Actual)
- Completion
- Dec 12, 2025 (Actual)
- Last update posted
- Jan 9, 2026
2023 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 21
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| Mayo Clinic-Arizona | Phoenix | Arizona | 85054 | — |
| Precision NextGen Oncology | Beverly Hills | California | 90212 | — |
| Sarcoma Oncology Center | Santa Monica | California | 90403 | — |
| University of California Los Angeles | Santa Monica | California | 90404 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Mayo Clinic - Florida | Jacksonville | Florida | 32224 | — |
| University Cancer and Blood Center | Athens | Georgia | 30607 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Cancer Center | Overland Park | Kansas | 66210 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63108 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| Northwell Health | Lake Success | New York | 11042 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Abramson Cancer Center at Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | — |
| West Cancer Center & Research Institute | Germantown | Tennessee | 38138 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Utah Cancer Specialists Cancer Center | Salt Lake City | Utah | 84106 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| Medical Oncology Associates, P.S. | Spokane | Washington | 99208 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06058793, 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 Jan 9, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06058793 live on ClinicalTrials.gov.