Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder
Public ClinicalTrials.gov record NCT05512377. 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-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of BI 907828 (Brigimadlin) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT05512377
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 99 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
- Dec 12, 2022
- Primary completion
- Sep 24, 2025
- Completion
- Sep 24, 2025
- Last update posted
- Jul 20, 2026
2022 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center | Mobile | Alabama | 36608 | — |
| University of Arizona | Tucson | Arizona | 85719 | — |
| University of Southern California | Los Angeles | California | 90033-9173 | — |
| Stanford Cancer Institute | Palo Alto | California | 94305 | — |
| Providence Medical Foundation-Santa Rosa -69764 | Santa Rosa | California | 95403 | — |
| Rocky Mountain Cancer Centers-Lone Tree-69498 | Lone Tree | Colorado | 80124 | — |
| Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Norton Cancer Institute, Downtown | Louisville | Kentucky | 40202 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Nebraska Cancer Specialists-Omaha-69066 | Omaha | Nebraska | 68130 | — |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10022 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oncology Associates of Oregon, PC | Eugene | Oregon | 97401 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
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 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05512377, 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 Jul 20, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05512377 live on ClinicalTrials.gov.