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

NCT05512377 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: 1403-00112023-506369-79-00U1111-1292-33922022-001500-18
• Study Type: interventional
• Target: 99
• Locations: 15 countries
• Sites: 56

Brief 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. 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.

Conditions

Pancreatic Neoplasms; Solid Tumors; Biliary Tract Cancer; Lung Neoplasms; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response (OR)

  OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1.

  Up to 30 months

Secondary Outcomes (10)

• Duration of objective response (DOR)

  Up to 30 months

• Progression-free survival (PFS)

  Up to 30 months

• Overall survival (OS)

  Up to 50 months

• Disease control (DC)

  Up to 30 months

• Occurrence of treatment-emergent adverse events (AEs) during the on-treatment period

  Up to 30 months

Study Arms (1)

brigimadlin (BI 907828) treatment arm

EXPERIMENTAL

Drug: brigimadlin

Interventions

brigimadlin DRUG

brigimadlin

Also known as: BI 907828

brigimadlin (BI 907828) treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (60)

Southern Cancer Center

Mobile, Alabama, 36608, United States

Location

University of Arizona

Tucson, Arizona, 85719, United States

Location

University of Southern California

Los Angeles, California, 90033-9173, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

Providence Medical Foundation-Santa Rosa -69764

Santa Rosa, California, 95403, United States

Location

Rocky Mountain Cancer Centers-Lone Tree-69498

Lone Tree, Colorado, 80124, United States

Location

Johns Hopkins Sidney Kimmel Cancer Center at Sibley Memorial Hospital

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

Location

Norton Cancer Institute, Downtown

Louisville, Kentucky, 40202, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Nebraska Cancer Specialists-Omaha-69066

Omaha, Nebraska, 68130, United States

Location

Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10022, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oncology Associates of Oregon, PC

Eugene, Oregon, 97401, United States

Location

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, 2031, Australia

Location

ICON-South Brisbane-69267

South Brisbane, Queensland, 4101, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Ordensklinikum Linz GmbH - Barmherzige Schwestern

Linz, 4020, Austria

Location

LK Wiener Neustadt

Wiener Neustadt, 2700, Austria

Location

Edegem - UNIV UZ Antwerpen

Edegem, 2650, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

CTR Georges-François Leclerc

Dijon, 21079, France

Location

INS Gustave Roussy

Villejuif, 94805, France

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Krankenhaus Nordwest, Frankfurt

Frankfurt, 60488, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum der Universität München AÖR

München, 81377, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

Kanagawa Cancer Center

Kanagawa, Yokohama, 241-8515, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

Location

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

Location

Yamaguchi University Hospital

Yamaguchi, Ube, 755-8505, Japan

Location

King Abdul Aziz Medical City

Riyadh, 11481, Saudi Arabia

Location

National University Hospital-Singapore-42005

Singapore, 119074, Singapore

Location

Rainbow Oncology

KwaZulu, 4126, South Africa

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

University Hospital Geneva

Geneva, CH-1211, Switzerland

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Location

China Medical University Hospital

Taichung, 404327, Taiwan

Location

National Taiwan University Cancer Center

Taipei, 106, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Songklanagarind Hospital

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital

Muang, 40002, Thailand

Location

University College Hospital

London, WC1E 6AG, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38214149 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms; Lung Neoplasms; Urinary Bladder Neoplasms

Interventions

brigimadlin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: December 13, 2022
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

SA (1); AU (2); BE (2); US (18); GB (1); ES (4); FR (2); SG (1); TW (4); DE (5); ZA (1); KR (4); CH (2); JP (7); TH (2)