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Cancer drug brigimadlin tested for Long-Term use in solid tumour patients

NCT ID NCT06619509

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 10 times

Summary

This study looks at the long-term safety of brigimadlin, a cancer drug taken as tablets, in adults with solid tumours who have already received at least 4 cycles of it in a previous study. About 90 participants will take the drug once every 3 weeks, and doctors will monitor their health and any side effects. The goal is to see if long-term treatment is tolerable and continues to benefit patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brigimadlin (BI 907828), an MDM2 inhibitor taken as tablets
What this could lead to
If successful, this could show that long-term brigimadlin is safe enough to continue treating solid tumours, potentially helping patients maintain disease control.
What could go wrong
This is a small, early-phase rollover study with no control group, so results may not apply broadly. Side effects could still emerge with longer use.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

90 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

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. Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial'). 2. 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 - Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses. 3. 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 \<1% per year when used consistently and correctly beginning at Screening, during trial participation, and until 6 months and 12 days after the last dose for women and 102 days after the last dose for men. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information. 4. Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures. 5. Adequate organ function. 6. Patient is eligible to receive continued treatment according to the clinical trial protocol of the parent trial they are currently participating in. Patients currently experiencing a dose delay in the parent trial due to adverse events are eligible if recovery from the adverse event takes place within the allowed time window in the parent trial. Exclusion criteria: 1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin. 2. Participants who must receive or intend to receive restricted medications or any drug 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 start of study treatment until 6 months and 12 days after the last dose of study treatment. 4. Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial. 5. Patient has an adverse event (AE) which has caused a dose delay and has not recovered within the allowed time window in the parent trial. 6. Patient who has already required 2 dose reductions and would require a third dose reduction at trial entry, unless the investigator deems treatment continuation beneficial, and the third dose reduction is agreed in writing between the investigator and the sponsor. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumours

Contacts and locations

Locations

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • CTR Eugène Marquis

    Rennes, 35042, France

  • CTR Leon Berard

    Lyon, 69373, France

  • Clinexpert Gyongyos

    Gyöngyös, 3200, Hungary

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100, Denmark

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Helios Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee, 37232, United States

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • Hospital Universitario Miguel Servet

    Aragon, 50009, Spain

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515, Japan

  • Karolinska Comprehensive Cancer Center

    Stockholm, SE-171 76, Sweden

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224, United States

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • Nebraska Cancer Specialists-Omaha-69066

    Omaha, Nebraska, 68130, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Okayama University Hospital

    Okayama, Okayama, 700-8558, Japan

  • Oncology Center-Maria Sklodowska-Curie Institute

    Warsaw, 02-781, Poland

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Oslo Universitetssykehus HF, Radiumhospitalet

    Oslo, N-0379, Norway

  • 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

  • Sanatorio Finochietto

    CABA, C1120AAB, Argentina

  • Sarcoma Oncology Center

    Santa Monica, California, 90403, United States

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • 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

  • UZ Leuven

    Leuven, 3000, Belgium

  • University College Hospital

    London, NW12PQ, United Kingdom

  • University Hospital Olomouc

    Olomouc, 77900, Czechia

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84106, 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, 06511, United States

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