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Liposarcoma, DedifferentiatedPhase 3NCT06058793

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

A Phase 3 study testing Brigimadlin in people with Liposarcoma, Dedifferentiated, run by Boehringer Ingelheim at 56 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liposarcoma, Dedifferentiated
What is being tested?
Brigimadlin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
56 sitesin 7 countries
Study dates
13 Dec 2023to 12 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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
  • Life expectancy ≥3 months at the start of treatment in the opinion of the investigator Further inclusion criteria apply.

Who cannot join

  • 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
  • Previous or concomitant malignancies other than the one treated in this study within the previous 2 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment Further exclusion criteria apply.

Trial locations and contacts

56 sites in 7 countries.

56 sites in 7 countries

United States26 sites

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • Precision NextGen Oncology

    Beverly Hills, California, 90212

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Northwestern University

    Chicago, Illinois, 60611

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224

  • Northwell Health

    Lake Success, New York, 11042

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Kansas Cancer Center

    Overland Park, Kansas, 66210

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Medical Oncology Associates, P.S.

    Spokane, Washington, 99208

  • Washington University School of Medicine

    St Louis, Missouri, 63108

Other trials in United States

Japan10 sites

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Okayama University Hospital

    Okayama, Okayama, 700-8558

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Brazil5 sites

  • Pronutrir

    Fortaleza, 60810-180

  • Hospital do Cancer de Londrina

    Londrina, 86015-520

  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

    Santo André, 09060-650

  • Hospital Sao Domingos

    São Luís, 65060-645

  • H.S.J. Beneficência Portuguesa - São Paulo

    São Paulo, 01323-001

Other trials in Brazil

Argentina4 sites

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB

  • Sanatorio Finochietto

    CABA, C1120AAB

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma de Bs As, C1426ANZ

Other trials in Argentina

Australia4 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

United Kingdom4 sites

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ

  • The Christie

    Manchester, M20 4BX

Other trials in United Kingdom

Canada3 sites

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Being tested
Brigimadlin
Medical subject headings
Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrigimadlinDrug

    Also called BI 907828

    Brigimadlin

Study groups in NCT06058793
Study groupRoleWhat they receive
Brigimadlin treatmentExperimentalNot described
Receives: Drug: Brigimadlin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 23 months

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

    Measured: up to 23 months

Secondary outcomes (10)

  1. Occurrence of treatment-emergent serious adverse events (SAEs)

    Measured: up to 23 months

  2. Occurrence of TEAEs leading to study treatment discontinuation

    Measured: up to 23 months

  3. Occurrence of TEAEs leading to dose reduction

    Measured: up to 23 months

  4. Occurrence of TEAEs leading to dose delay

    Measured: up to 23 months

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

    Measured: up to 23 months

  6. Objective response (OR)

    OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (based on investigator assessment) from the date of treatment start until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, withdrawal of consent or end of study (EoS)

    Measured: up to 23 months

  7. Progression-free survival (PFS)

    PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1, based on investigator assessment, or death from any cause

    Measured: up to 23 months

  8. Overall survival (OS)

    OS is defined as the time from treatment start until death from any cause

    Measured: up to 23 months

  9. Duration of objective response (DOR)

    DOR is defined as the time from first documented confirmed OR until the earliest date of disease progression or death among patients with confirmed OR (based on investigator assessment)

    Measured: up to 23 months

  10. Disease control (DC)

    DC is defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1 based on investigator assessment

    Measured: up to 23 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start13 Dec 2023
  3. Primary completion12 Dec 2025
  4. Study completion12 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06058793
Sponsor's protocol ID
1403-0019
Other IDs
2023-504522-19-00, 2023
Status last verified
Jan 2026
First submitted
22 Sep 2023
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brigimadlin in people with Liposarcoma, Dedifferentiated, run by Boehringer Ingelheim at 56 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Japan, Brazil, Argentina, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Treatment-emergent adverse events (TEAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 during the entire treatment period (time frame: up to 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06058793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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