A Study to Test Long-term Treatment With Brigimadlin in People With Solid Tumours Who Took Part in a Previous Study With This Medicine

Last updated: March 5, 2026
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

All Solid Tumors

Treatment

Brigimadlin

Clinical Study ID

NCT06619509
1403-0032
2024-514177-21-00
U1111-1305-3484
  • Ages > 18
  • All Genders

Study Summary

This study is open to adults with solid tumours who received at least 4 cycles of treatment with brigimadlin in a previous study. The goal of this study is to find out how well people with solid tumours tolerate long-term treatment with brigimadlin. Brigimadlin is a so-called MDM2 inhibitor that was being developed to treat cancer.

All participants take brigimadlin as tablets once every 3 weeks at the study site. At study visits, doctors check participants' health and take note of any unwanted effects. At some study visits, doctors also check the size of the tumour and whether it has spread to other parts of the body. Participants are in the study as long as they benefit from treatment and can tolerate it.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Patient is ongoing on brigimadlin treatment in any trial sponsored by BoehringerIngelheim (hereafter referred to as the 'parent trial').

  2. Provision of signed and dated, written informed consent form (ICF) in accordancewith International Council for Harmonisation of Technical Requirements forPharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and locallegislation prior to any trial-specific procedures, sampling, or analyses.

  3. Women of childbearing potential (WOCBP) and men able to father a child must be readyand able to use 2 medically acceptable methods of birth control per ICH M3 (R2) thatresult in a low failure rate of <1% per year when used consistently and correctlybeginning at Screening, during trial participation, and until 6 months and 12 daysafter the last dose for women and 102 days after the last dose for men. A list ofcontraception methods meeting these criteria and instructions on the duration of useis provided in the participant information.

  4. Participants must be willing and able to comply with the scheduled visits, treatmentplan, lifestyle, laboratory tests, contraceptive guidelines, and other studyprocedures.

  5. Adequate organ function.

  6. Patient is eligible to receive continued treatment according to the clinical trialprotocol of the parent trial they are currently participating in. Patients currentlyexperiencing a dose delay in the parent trial due to adverse events are eligible ifrecovery from the adverse event takes place within the allowed time window in theparent trial.

Exclusion

Exclusion criteria:

  1. Any medical condition which in the opinion of the investigator should exclude thepatient from receiving treatment with brigimadlin.

  2. Participants who must receive or intend to receive restricted medications or anydrug considered likely to interfere with the safe conduct of the trial.

  3. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.Female patients who do not agree to the interruption of breastfeeding from the startof study treatment until 6 months and 12 days after the last dose of studytreatment.

  4. Patient has unacceptable toxicity on brigimadlin at the time of transition into thistrial.

  5. Patient has an adverse event (AE) which has caused a dose delay and has notrecovered within the allowed time window in the parent trial.

  6. Patient who has already required 2 dose reductions and would require a third dosereduction at trial entry, unless the investigator deems treatment continuationbeneficial, and the third dose reduction is agreed in writing between theinvestigator and the sponsor.

Further exclusion criteria apply.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: Brigimadlin
Phase: 2
Study Start date:
December 30, 2024
Estimated Completion Date:
December 30, 2030

Connect with a study center

  • Sanatorio Finochietto

    CABA, C1120AAB
    Argentina

    Site Not Available

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Prince of Wales Hospital-Randwick-66496

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 4102
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc

    Brussels 2800866, 1200
    Belgium

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

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

    Sao Paulo, 01323-001
    Brazil

    Site Not Available

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

    São Paulo 3448439, 01323-001
    Brazil

    Site Not Available

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary 5913490, Alberta 5883102 T2N 5G2
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • West China Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Wuhan Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • University Hospital Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • University Hospital Olomouc

    Olomouc 3069011, 77900
    Czechia

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100
    Denmark

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet

    København Ø 11746747, 2100
    Denmark

    Site Not Available

  • CTR Leon Berard

    Lyon, 69373
    France

    Site Not Available

  • CTR Leon Berard

    Lyon 2996944, 69373
    France

    Site Not Available

  • CTR Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • CTR Eugène Marquis

    Rennes 2983990, 35042
    France

    Site Not Available

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Helios Klinikum Berlin-Buch

    Berlin 2950159, 13125
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen 2820860, 72076
    Germany

    Site Not Available

  • Clinexpert Gyongyos

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Clinexpert Gyongyos

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • Clinexpert Gyongyos

    Gyöngyös 3052040, 3200
    Hungary

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan 6951411, 20133
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padua, 35128
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, Okayama, 700-8558
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045
    Japan

    Site Not Available

  • Nederlands Kanker Instituut

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0379
    Norway

    Site Not Available

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo 3143244, N-0379
    Norway

    Site Not Available

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781
    Poland

    Site Not Available

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw 756135, 02-781
    Poland

    Site Not Available

  • Hospital Miguel Servet

    Aragon, 50009
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Aragon, 50009
    Spain

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Site Not Available

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Quirónsalud Madrid

    Madrid, 28223
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital Universitario HM Sanchinarro

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Clínico de Santiago

    Santiago de Compostela 3109642, 15706
    Spain

    Site Not Available

  • Hospital Clínico de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Karolinska Comprehensive Cancer Center

    Stockholm, SE-171 76
    Sweden

    Site Not Available

  • Karolinska Comprehensive Cancer Center

    Stockholm 2673730, SE-171 76
    Sweden

    Site Not Available

  • University Hospital Bern/Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital, Chelsea

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital

    London, NW12PQ
    United Kingdom

    Site Not Available

  • The Royal Marsden Hospital, Chelsea

    London 2643743, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital

    London 2643743, NW12PQ
    United Kingdom

    Site Not Available

  • Precision NextGen Oncology

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica, California 90403
    United States

    Site Not Available

  • Precision NextGen Oncology

    Beverly Hills 5328041, California 5332921 90212
    United States

    Site Not Available

  • Sarcoma Oncology Center

    Santa Monica 5393212, California 5332921 90403
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06511
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63108
    United States

    Site Not Available

  • Nebraska Cancer Specialists-Omaha-69066

    Omaha, Nebraska 68130
    United States

    Site Not Available

  • Nebraska Cancer Specialists-Omaha-69066

    Omaha 5074472, Nebraska 5073708 68130
    United States

    Site Not Available

  • Northwell Health

    Lake Success, New York 11042
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Northwell Health

    Lake Success 5123853, New York 5128638 11042
    United States

    Site Not Available

  • West Cancer Center & Research Institute

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • West Cancer Center & Research Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Utah Cancer Specialists Cancer Center

    Salt Lake City 5780993, Utah 5549030 84106
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington 98109
    United States

    Site Not Available

  • Fred Hutchinson Cancer Research Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.