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New pill shows promise in rare cancer fight

NCT ID NCT05218499

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, brigimadlin, against standard chemo (doxorubicin) in 400 adults with advanced dedifferentiated liposarcoma. Participants took either the pill or received chemo infusions every 3 weeks. The goal was to see which treatment better slowed tumor growth. This is not a cure, but aims to control the disease.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

400 people

The number who actually took part.

Started

Mar 2022

Finished

Jan 2026

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: * Provision of signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses. * Male or female patients ≥18 years old at the time of signature of the informed consent form (ICF). Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use 2 medically acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at screening, during trial 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 proven locally advanced or metastatic, unresectable (surgery morbidity would outweigh potential benefits), progressive or recurrent dedifferentiated liposarcoma (DDLPS). Locally performed histopathological diagnosis will be accepted for entry into this trial but will be confirmed by independent pathological review while the patients receive treatment in this trial. * Written pathology report indicating the diagnosis of DDLPS with positive mouse double minute 2 homolog (MDM2) immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization or next generation sequencing (NGS) must be available. * Formalin fixed paraffin embedded tumor blocks or slides must be available for retrospective histopathological central review. * Presence of at least one measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. In patients who only have one 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 (PS) of 0 or 1. * Patient must be willing to donate blood samples for the pharmacokinetics, pharmacodynamics, and tumor mutation analysis. * Patient willing to undergo a mandatory tumor biopsy at the time point specified in the flowchart unless exempt. * Adequate organ function. Exclusion Criteria: * 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 randomization or planned within 6 months after screening. * Prior systemic therapy for liposarcoma in any setting (including adjuvant, neoadjuvant, maintenance, palliative). * Previous or concomitant malignancies other than DDLPS or WDLPS, treated within the previous 5 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. * Previous treatment with anthracyclines in any setting (systemic treatment with other anticancer agents is allowed if completed at least 5 years prior to study entry with the exception of hormone therapy). * Patients who must or intend to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. * Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). * Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant). * 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

  • "Attikon" University General Hospital of Attica

    Haidari, 12462, Greece

  • AOU San Luigi Gonzaga

    Orbassano (TO), 10043, Italy

  • Abdurrahman Yurtaslan Oncology Training and Research Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681, Japan

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037, Australia

  • Asklepios Kliniken GmbH & Co. KGaA

    Hamburg, 22763, Germany

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90129, Italy

  • BC Cancer Agency - Vancouver

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Bioclinic Thessaloniki

    Thessaloniki, 54622, Greece

  • CTR Eugène Marquis

    Rennes, 35042, France

  • CTR Leon Berard

    Lyon, 69373, France

  • CTR Oscar Lambret

    Lille, 59020, France

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021, China

  • Churchill Hospital

    Headington, OX3 9DS, United Kingdom

  • City of Hope-Duarte-56419

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • HOP Timone

    Marseille, 13385, France

  • HUCH Comprehensive Cancer Center, building 2

    Helsinki, 00290, Finland

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526, Germany

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Herlev and Gentofte Hospital

    Herlev, 2730, Denmark

  • Hippokration General Hospital of Athen

    Athens, 115 27, Greece

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Humanitas Gavazzeni

    Bergamo, 24125, Italy

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Hôpital Cochin

    Paris, 75014, France

  • INS Bergonie

    Bordeaux, 33000, France

  • INS Claudius Regaud IUCT-Oncopole

    Toulouse, 31059, France

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023, Portugal

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Istituto Di Candiolo

    Candiolo (TO), 10060, Italy

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • Karolinska Universitetssjukhuset Stockholm

    Stockholm, 17177, Sweden

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2333 ZA, Netherlands

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4, Canada

  • Masaryk Memorial Cancer Institute

    Brno, 65653, Czechia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic, Rochester

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560, Japan

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Nebraska Cancer Specialists-Omaha-69502

    Omaha, Nebraska, 68114, United States

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX, Netherlands

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Oregon Health and Sciences University

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0379, Norway

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Precision NextGen Oncology

    Beverly Hills, California, 90212, United States

  • Prince of Wales Hospital-Hong Kong-20715

    Hong Kong, Hong Kong

  • 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

  • Robert Bosch Gesellschaft für medizinische Forschung mbH

    Stuttgart, 70376, Germany

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Skånes universitetssjukhus

    Lund, 22185, Sweden

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Technische Universität Dresden

    Dresden, 01307, Germany

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ, United Kingdom

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • ULS de Santa Maria, E.P.E

    Lisbon, 1649-035, Portugal

  • UZ Leuven

    Leuven, 3000, Belgium

  • University College Hospital

    London, NW1 2BU, United Kingdom

  • University Hospital Motol

    Prague, 150 06, Czechia

  • University Hospital Olomouc

    Olomouc, 77900, Czechia

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Arizona

    Tucson, Arizona, 85719, United States

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Università Campus Bio-Medico - ROMA

    Roma, 00128, Italy

  • Universitätsklinikum Essen AöR

    Essen, 45147, Germany

  • Universitätsklinikum Mannheim GmbH

    Mannheim, 68167, Germany

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Wuhan Union Hospital

    Wuhan, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, 200032, China

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