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Promising new pill targets rare cancer in phase 3 trial

NCT ID NCT06058793

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new cancer pill called brigimadlin in 138 adults with a rare type of fat-tissue cancer (dedifferentiated liposarcoma). The pill works by blocking a protein that helps the cancer grow. Participants took the pill once every three weeks, and doctors monitored side effects and tumor changes. The goal was to see if the drug is safe and can shrink or slow the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

138 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 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 8. Life expectancy ≥3 months at the start of treatment in the opinion of the investigator Further inclusion criteria apply. Exclusion Criteria: 1. Known mutation in the TP53 gene (screening for TP53 status is not required) 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 8. 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.

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Conditions

The condition(s) this trial relates to.

dedifferentiated liposarcoma liposarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liposarcoma, dedifferentiated

Contacts and locations

Locations

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106, United States

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681, Japan

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

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

    Santo André, 09060-650, Brazil

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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

    São Paulo, 01323-001, Brazil

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • Hospital Britanico de Buenos Aires

    CABA, 1280AEB, Argentina

  • Hospital Italiano de Buenos Aires

    CABA, C1199ABB, Argentina

  • Hospital Sao Domingos

    São Luís, 65060-645, Brazil

  • Hospital do Cancer de Londrina

    Londrina, 86015-520, Brazil

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Instituto Medico Especializado Alexander Fleming

    Ciudad Autonoma de Bs As, C1426ANZ, Argentina

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Mayo Clinic - Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054, United States

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1, Canada

  • Medical Oncology Associates, P.S.

    Spokane, Washington, 99208, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Precision NextGen Oncology

    Beverly Hills, California, 90212, United States

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Pronutrir

    Fortaleza, 60810-180, Brazil

  • Sanatorio Finochietto

    CABA, C1120AAB, Argentina

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009, Australia

  • The Christie

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • University Cancer and Blood Center

    Athens, Georgia, 30607, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of Kansas Cancer Center

    Overland Park, Kansas, 66210, United States

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84106, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.