This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
NCT ID: NCT03449381
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
266 participants
INTERVENTIONAL
2018-06-20
2025-11-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab)
NCT03964233
A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps
NCT07224425
Weekly BI 836880 in Patients With Advanced Solid Tumors
NCT02689505
A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body
NCT05613036
BI 811283 in Various Solid Tumours
NCT00701324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dose Escalation
BI 907828
Film-coated tablet
Dose Expansion
BI 907828
Film-coated tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BI 907828
Film-coated tablet
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pathologically documented, advanced solid tumors.
* Patients fulfilling one or more of the following criteria:
* Radiologically documented disease progression or relapse
* Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist.
* Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only).
* Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria to be considered eligible.
* Phase Ia (dose escalation) only:
* Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry.
* Phase Ib (expansion phase) only:
* Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included if agreed between the Investigator and Sponsor.
* Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
* Phase Ia (dose escalation) only:
* Patient with either measurable or non-measurable disease.
* Non-evaluable disease allowed.
* Phase Ib (expansion phase) only:
* At least one target lesion that can be accurately measured per RECIST v.1.1.
* Phase Ia:
* Patient must be willing to undergo blood sampling for PK, pharmacodynamic, biomarker, and PGx analyses.
* Phase Ib:
* Patient must be willing to undergo tumor biopsy sampling for pharmacodynamic analyses and blood sampling for PK, pharmacodynamics, and biomarker analyses.
* Willingness to provide a fresh tumor tissue sample obtained after relapse/ progression during or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen, collected before screening within 12 months of enrollment, may be submitted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and Sponsor.
Exclusion Criteria
* Known TP53 mutant tumor.
* Symptomatic metastases from non-brain tumors. Note: Patients with previously treated brain metastases may participate provided they are stable, without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or computed tomography (CT) scan), for at least four weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline; have no evidence of new or enlarging brain metastases. Patients on corticosteroids must have a stable dose for at least 5 days prior to baseline MRI.
* Patients with history of bleeding diathesis.
* Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to start of study treatment, or planned within 12 months after screening (e.g. hip replacement).
* Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sarcoma Oncology Center
Santa Monica, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Florida Cancer Specialists-Sarasota-61670
Sarasota, Florida, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
START Midwest
Grand Rapids, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
The Ottawa Hospital
Ottawa, Ontario, Canada
Rigshospitalet, København
København Ø, , Denmark
Helios Klinikum Berlin-Buch
Berlin, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Sourasky Medical Center
Tel Aviv, , Israel
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Poznan, , Poland
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, , Poland
Severance Hospital
Seoul, , South Korea
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Clínico de Santiago
Santiago de Compostela, , Spain
Karolinska Comprehensive Cancer Center
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
LoRusso P, Yamamoto N, Patel MR, Laurie SA, Bauer TM, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder MM. The MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study. Cancer Discov. 2023 Aug 4;13(8):1802-1813. doi: 10.1158/2159-8290.CD-23-0153.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003210-95
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1403-0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.