Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma

NCT06058793 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 1403-00192023-504522-19-00
• Study Type: interventional
• Target: 138
• Locations: 7 countries
• Sites: 56

Brief Summary

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.

Conditions

Liposarcoma, Dedifferentiated

Outcome Measures

Primary Outcomes (2)

• Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period

  up to 23 months

• Occurrence of TEAEs with Grade ≥3 according to CTCAE version 5 during the entire treatment period

  up to 23 months

Secondary Outcomes (10)

• Occurrence of treatment-emergent serious adverse events (SAEs)

  up to 23 months

• Occurrence of TEAEs leading to study treatment discontinuation

  up to 23 months

• Occurrence of TEAEs leading to dose reduction

  up to 23 months

• Occurrence of TEAEs leading to dose delay

  up to 23 months

• Occurrence of TEAEs of special interest (adverse events of special interest [AESIs])

  up to 23 months

Study Arms (1)

Brigimadlin treatment

EXPERIMENTAL

Drug: Brigimadlin

Interventions

Brigimadlin DRUG

Brigimadlin

Also known as: BI 907828

Brigimadlin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to any study-specific procedures, sampling, or analyses
• Male or female patients ≥18 years old at the time of signature of the ICF
• 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
• 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)
• 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)
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Known mutation in the TP53 gene (screening for TP53 status is not required)
• 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
• Previous administration of brigimadlin or any other MDM2-p53 or MDM4 regulator of p53 (MDM4/MDMX)-p53 antagonist
• Previous treatment in study 1403-0008 (Brightline-1)
• Having to receive, or intending to receive, restricted medications or any drug considered likely to interfere with the safe conduct of the study
• Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment
• Unable to swallow the study treatment

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (56)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Mayo Clinic-Arizona

Phoenix, Arizona, 85054, United States

Location

Precision NextGen Oncology

Beverly Hills, California, 90212, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University of California Los Angeles

Santa Monica, California, 90404, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic - Florida

Jacksonville, Florida, 32224, United States

Location

University Cancer and Blood Center

Athens, Georgia, 30607, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Cancer Center

Overland Park, Kansas, 66210, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Utah Cancer Specialists Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Medical Oncology Associates, P.S.

Spokane, Washington, 99208, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Hospital Britanico de Buenos Aires

CABA, 1280AEB, Argentina

Location

Sanatorio Finochietto

CABA, C1120AAB, Argentina

Location

Hospital Italiano de Buenos Aires

CABA, C1199ABB, Argentina

Location

Instituto Medico Especializado Alexander Fleming

Ciudad Autonoma de Bs As, C1426ANZ, Argentina

Location

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, 2031, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Pronutrir

Fortaleza, 60810-180, Brazil

Location

Hospital do Cancer de Londrina

Londrina, 86015-520, Brazil

Location

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, 09060-650, Brazil

Location

Hospital Sao Domingos

São Luís, 65060-645, Brazil

Location

H.S.J. Beneficência Portuguesa - São Paulo

São Paulo, 01323-001, Brazil

Location

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

Location

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681, Japan

Location

Nagoya University Hospital

Aichi, Nagoya, 466-8560, Japan

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Okayama University Hospital

Okayama, Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

The Royal Marsden Hospital, Chelsea

London, SW3 6JJ, United Kingdom

Location

The Christie

Manchester, M20 4BX, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liposarcoma

Interventions

brigimadlin

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: December 13, 2023
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

CA (3); AU (4); GB (4); BR (5); US (26); JP (10); AR (4)