Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
NCT ID: NCT06058793
Last Updated: 2025-11-12
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
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ACTIVE_NOT_RECRUITING
PHASE3
138 participants
INTERVENTIONAL
2023-12-13
2025-12-18
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brigimadlin treatment
Brigimadlin
Brigimadlin
Interventions
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Brigimadlin
Brigimadlin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients ≥18 years old at the time of signature of the ICF
3. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of \<1% per year when used consistently and correctly beginning at screening, during study participation, and until 6 months and 12 days after last dose for women and 102 days after last dose for men. A list of contraception methods meeting these criteria is provided in the patient information
4. Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:
* Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
* Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
5. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
6. Presence of at least 1 measurable target lesion according to RECIST version 1.1. In patients who only have 1 target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria
2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment or planned within 6 months after screening
3. Previous administration of brigimadlin or any other MDM2-p53 or MDM4 regulator of p53 (MDM4/MDMX)-p53 antagonist
4. Previous treatment in study 1403-0008 (Brightline-1)
5. Having to receive, or intending to receive, restricted medications or any drug considered likely to interfere with the safe conduct of the study
6. Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment
7. Unable to swallow the study treatment
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic-Arizona
Phoenix, Arizona, United States
Precision NextGen Oncology
Beverly Hills, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of California Los Angeles
Santa Monica, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
University Cancer and Blood Center
Athens, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Kansas Cancer Center
Overland Park, Kansas, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
West Cancer Center & Research Institute
Germantown, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical Oncology Associates, P.S.
Spokane, Washington, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires
CABA, , Argentina
Sanatorio Finochietto
CABA, , Argentina
Hospital Italiano de Buenos Aires
CABA, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma de Bs As, , Argentina
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Pronutrir
Fortaleza, , Brazil
Hospital do Cancer de Londrina
Londrina, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, , Brazil
Hospital Sao Domingos
São Luís, , Brazil
H.S.J. Beneficência Portuguesa - São Paulo
São Paulo, , Brazil
Arthur J. E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
Nagoya University Hospital
Aichi, Nagoya, , Japan
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, , Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
Addenbrooke's Hospital
Cambridge, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
The Royal Marsden Hospital, Chelsea
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2023-504522-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
1403-0019
Identifier Type: -
Identifier Source: org_study_id