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AzTrials

Pancreatic NeoplasmsPhase 2NCT05512377

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

A Phase 2 study testing Brigimadlin in people with Pancreatic Neoplasms and Solid Tumors, run by Boehringer Ingelheim at 60 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brigimadlin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
60 sitesin 16 countries
Study dates
13 Dec 2022to 25 Sep 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

60 sites in 16 countries.

60 sites in 16 countries

United States18 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Oncology Associates of Oregon, PC

    Eugene, Oregon, 97401

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Rocky Mountain Cancer Centers-Lone Tree-69498

    Lone Tree, Colorado, 80124

  • University of Southern California

    Los Angeles, California, 90033-9173

  • Norton Cancer Institute, Downtown

    Louisville, Kentucky, 40202

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10022

  • Nebraska Cancer Specialists-Omaha-69066

    Omaha, Nebraska, 68130

  • Stanford Cancer Institute

    Palo Alto, California, 94305

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • Providence Medical Foundation-Santa Rosa -69764

    Santa Rosa, California, 95403

  • University of Arizona

    Tucson, Arizona, 85719

  • Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

Japan7 sites

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

  • Yamaguchi University Hospital

    Yamaguchi, Ube, 755-8505

Other trials in Japan

Germany5 sites

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Krankenhaus Nordwest, Frankfurt

    Frankfurt, 60488

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Klinikum der Universität München AÖR

    München, 81377

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Australia4 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Austin Health

    Heidelberg, Victoria, 3084

  • Prince of Wales Hospital-Randwick-66496

    Randwick, New South Wales, 2031

  • ICON-South Brisbane-69267

    South Brisbane, Queensland, 4101

Other trials in Australia

South Korea4 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • China Medical University Hospital

    Taichung, 404327

  • National Taiwan University Cancer Center

    Taipei, 106

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Austria2 sites

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, 4020

  • LK Wiener Neustadt

    Wiener Neustadt, 2700

Other trials in Austria

Belgium2 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

France2 sites

  • CTR Georges-François Leclerc

    Dijon, 21079

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Switzerland2 sites

  • University Hospital Bern

    Bern, 3010

  • University Hospital Geneva

    Geneva, CH-1211

Other trials in Switzerland

Thailand2 sites

  • Songklanagarind Hospital

    Hat Yai, 90110

  • Srinagarind Hospital

    Muang, 40002

Other trials in Thailand

Saudi Arabia1 site

  • King Abdul Aziz Medical City

    Riyadh, 11481

Other trials in Saudi Arabia

Singapore1 site

  • National University Hospital-Singapore-42005

    Singapore, 119074

Other trials in Singapore

South Africa1 site

  • Rainbow Oncology

    KwaZulu, 4126

Other trials in South Africa

United Kingdom1 site

  • University College Hospital

    London, WC1E 6AG

Other trials in United Kingdom

About this study

Official title: Brightline-2: A Phase IIa/IIb, Open-label, Single-arm, Multi-centre Trial of BI 907828 (Brigimadlin) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.

The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Being tested
Brigimadlin
Medical subject headings
Pancreatic Neoplasms, Biliary Tract Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrigimadlinDrug

    Also called BI 907828

    Patients received brigimadlin 45 mg orally on Day 1 of each 21-day cycle.

Study groups in NCT05512377
Study groupRoleWhat they receive
Brigimadlin 45 mg: Cohort 1 (biliary tract adenocarcinoma)ExperimentalPatients with locally advanced / metastatic MDM2 amplified, TP53 wild-type biliary tract adenocarcinoma received brigimadlin 45 milligram (mg) orally on Day 1 of each 21-day cycle. Patients continued to receive treatment with brigimadlin until disease progression (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST) or until another reason requiring termination of treatment.
Receives: Drug: Brigimadlin
Brigimadlin 45 mg: Cohort 2 (pancreatic ductal adenocarcinoma)ExperimentalPatients with locally advanced / metastatic MDM2 amplified, TP53 wild-type pancreatic ductal adenocarcinoma received brigimadlin 45 mg orally on Day 1 of each 21-day cycle. Patients continued to receive treatment with brigimadlin until disease progression (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST) or until another reason requiring termination of treatment.
Receives: Drug: Brigimadlin
Brigimadlin 45 mg: Cohort 3 (lung adenocarcinoma)ExperimentalPatients with locally advanced / metastatic MDM2 amplified, TP53 wild-type lung adenocarcinoma received brigimadlin 45 mg orally on Day 1 of each 21-day cycle. Patients continued to receive treatment with brigimadlin until disease progression (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST) or until another reason requiring termination of treatment.
Receives: Drug: Brigimadlin
Brigimadlin 45 mg: Cohort 4 (urothelial bladder cancer)ExperimentalPatients with locally advanced / metastatic MDM2 amplified, TP53 wild-type urothelial bladder cancer received brigimadlin 45 mg orally on Day 1 of each 21-day cycle. Patients continued to receive treatment with brigimadlin until disease progression (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST) or until another reason requiring termination of treatment.
Receives: Drug: Brigimadlin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response (OR)

    OR based on central independent review is reported. OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

    Measured: From the date of treatment start until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 25.0 months.

Secondary outcomes (6)

  1. Duration of Objective Response (DOR)

    DOR based on central independent review is reported. DOR was defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response.

    Measured: From first documented confirmed objective response (OR) until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 23.9 months.

  2. Progression-free Survival (PFS)

    PFS based on central independent review. PFS was defined as the time from treatment start until the earliest date of tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

    Measured: From treatment start until the earliest date of tumour progression according to RECIST version 1.1 or death from any cause, whichever occurs first. Up to 25.0 months.

  3. Overall Survival (OS)

    OS was defined as the time from treatment start until death from any cause.

    Measured: From treatment start until death from any cause. Up to 28.1 months.

  4. Disease Control (DC)

    DC based on central independent review is reported. DC was defined as a best overall response of CR, PR, or stable disease (SD) where best overall response is defined according to RECIST version 1.1.

    Measured: From the date of treatment start until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 25.0 months.

  5. Occurrence of Treatment-emergent Adverse Events (AEs) During the On-treatment Period

    Occurrence of treatment-emergent AEs during the on-treatment period is reported as count of participants with treatment-emergent AEs during the on-treatment period.

    Measured: From first day of administration of brigimadlin until last administration of brigimadlin plus 30 days of residual effect period (REP), up to 28.4 months.

  6. Occurrence of Treatment-emergent AEs Leading to Trial Drug Discontinuation During the On-treatment Period

    Occurrence of treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period is reported as count of participants with treatment-emergent AEs leading to trial drug discontinuation during the on-treatment period.

    Measured: From first day of administration of brigimadlin until last administration of brigimadlin plus 30 days of residual effect period (REP), up to 28.4 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start13 Dec 2022
  3. Primary completion25 Sep 2025
  4. Study completion25 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512377
Sponsor's protocol ID
1403-0011
Other IDs
2023-506369-79-00, U1111-1292-3392, 2022-001500-18, 2023
Status last verified
Sep 2026
First submitted
22 Aug 2022
Last updated
14 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Publications

  • Yoo C, Lamarca A, Choi HJ, Vogel A, Pishvaian MJ, Goyal L, Ueno M, Marten A, Teufel M, Geng L, Morizane C. Brightline-2: a phase IIa/IIb trial of brigimadlin (BI 907828) in advanced biliary tract cancer, pancreatic ductal adenocarcinoma or other solid tumors. Future Oncol. 2024;20(16):1069-1077. doi: 10.2217/fon-2023-0963. Epub 2024 Jan 12.

    PubMed 38214149

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brigimadlin in people with Pancreatic Neoplasms and Solid Tumors, run by Boehringer Ingelheim at 60 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in United States, Japan, Germany, Australia, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) (time frame: From the date of treatment start until the earliest date of disease progression according to RECIST version 1.1 or death. Up to 25.0 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05512377, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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