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Experimental cancer pill targets genetic weakness in Hard-to-Treat tumors

NCT ID NCT05512377

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study tested a new drug called brigimadlin (BI 907828) in 99 adults with advanced cancers of the bile duct, pancreas, lung, or bladder that have a specific genetic change (MDM2 amplification). Participants took the drug as a tablet once every 3 weeks. The goal was to see if the drug could shrink tumors. However, the study was terminated early, so results are not yet available.

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 a tablet
What this could lead to
If it works, this could provide a new treatment option for people with certain advanced cancers that have a specific genetic change (MDM2 amplification).
What could go wrong
This is an early-phase (Phase II) trial that was terminated, so results are limited. The drug may not shrink tumors or improve survival, and side effects are possible.

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

99 people

The number who actually took part.

Started

Dec 2022

Finished

Sep 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: * Diagnosis of a solid tumour which meets the criteria for an open trial cohort: * Cohorts 1 and 1-CN (biliary tract adenocarcinoma): Locally advanced or metastatic biliary tract adenocarcinoma (intra- and extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary cancer).Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards; or (in the opinion of the investigator) patients are unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy. * Cohort 2 (pancreatic ductal adenocarcinoma): Locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards. * Cohort 3 (lung adenocarcinoma): Locally advanced or metastatic lung adenocarcinoma. Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards. * Cohort 4 (urothelial bladder cancer): Locally advanced or metastatic urothelial bladder cancer. Patients must have unresectable disease and have received all available conventional therapies known to confer clinical benefit for their disease based on local approved standards. * Written pathology report / molecular profiling report indicating Mouse double minute 2 homolog (MDM2) amplification or a copy number ≥8 and tumor protein 53 (TP53) wild-type status. This must have been confirmed with a tissue-based test. A test with liquid biopsy is not accepted. * Archival tissue (formalin fixed paraffin embedded \[FFPE\] tumour blocks or slides) must be provided for retrospective confirmation of MDM2 amplification and TP53 status. * Presence of at least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Patient must be willing to donate mandatory blood samples for the pharmacokinetics, pharmacodynamics, and biomarker analyses * Adequate organ function * All toxicities related to previous anti-cancer therapies have resolved to ≤Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and amenorrhea / menstrual disorders which can be of any grade and peripheral neuropathy which must be ≤CTCAE Grade 2). * Life expectancy ≥3 months at the start of treatment in the opinion of the investigator. * 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 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. Exclusion Criteria: * Previous administration of brigimadlin (BI 907828) or any other MDM2-p53 or mouse double minute 4 (MDMX, MDM4)-p53 antagonist. * Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease). * Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of trial treatment or planned within 6 months after screening (e.g. hip replacement). * Clinically significant previous or concomitant malignancies in the opinion of the investigator affecting the efficacy and/or outcome of the trial. * 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. * Any history of, or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the trial drug. * 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.

bile duct adenocarcinoma biliary tract cancer Biliary Tract Neoplasms bladder transitional cell carcinoma lung adenocarcinoma lung neoplasm pancreatic ductal adenocarcinoma pancreatic neoplasm urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Biliary tract cancer Bladder cancer Lung neoplasms Pancreatic neoplasms Solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • CTR Georges-François Leclerc

    Dijon, 21079, France

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • ICON-South Brisbane-69267

    South Brisbane, Queensland, 4101, Australia

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550, Japan

  • Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • King Abdul Aziz Medical City

    Riyadh, 11481, Saudi Arabia

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • Krankenhaus Nordwest, Frankfurt

    Frankfurt, 60488, Germany

  • LK Wiener Neustadt

    Wiener Neustadt, 2700, Austria

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10022, United States

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • National Taiwan University Cancer Center

    Taipei, 106, Taiwan

  • National University Hospital-Singapore-42005

    Singapore, 119074, Singapore

  • Nebraska Cancer Specialists-Omaha-69066

    Omaha, Nebraska, 68130, United States

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202, United States

  • Oncology Associates of Oregon, PC

    Eugene, Oregon, 97401, United States

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, 4020, Austria

  • Oregon Health and Sciences University

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501, United States

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031, Australia

  • Providence Medical Foundation-Santa Rosa -69764

    Santa Rosa, California, 95403, United States

  • Rainbow Oncology

    KwaZulu, 4126, South Africa

  • Rocky Mountain Cancer Centers-Lone Tree-69498

    Lone Tree, Colorado, 80124, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Songklanagarind Hospital

    Hat Yai, 90110, Thailand

  • Southern Cancer Center

    Mobile, Alabama, 36608, United States

  • Srinagarind Hospital

    Muang, 40002, Thailand

  • Stanford Cancer Institute

    Palo Alto, California, 94305, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574, Japan

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University College Hospital

    London, WC1E 6AG, United Kingdom

  • University Hospital Bern

    Bern, 3010, Switzerland

  • University Hospital Geneva

    Geneva, CH-1211, Switzerland

  • University of Arizona

    Tucson, Arizona, 85719, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Southern California

    Los Angeles, California, 90033-9173, United States

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Yamaguchi University Hospital

    Yamaguchi, Ube, 755-8505, Japan

More trials for these conditions

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