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

A Phase II, Single-arm, Open-label, Long-term Safety Rollover Trial of Oral Brigimadlin in Patients With Solid Tumours

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumours
• Intervention / Treatment: Drug: Brigimadlin

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • CABA, Argentina, C1120AAB
    • Sanatorio Finochietto
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital-Randwick-66496
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • UZ Leuven
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Arthur J. E. Child Comprehensive Cancer Centre
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
• China
  • Guangzhou, China, 510060
    • Sun Yat-Sen University Cancer Center
• Czechia
  • Olomouc, Czechia, 77900
    • University Hospital Olomouc
• Denmark
  • København Ø, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet
• France
  • Lyon, France, 69373
    • CTR Leon Berard
  • Rennes, France, 35042
    • CTR Eugène Marquis
• Germany
  • Berlin, Germany, 13125
    • Helios Klinikum Berlin-Buch
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen
• Hungary
  • Gyöngyös, Hungary, 3200
    • Clinexpert Gyongyos
• Israel
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center
• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
• Japan
  • Fukuoka, Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Kanagawa, Yokohama, Japan, 241-8515
    • Kanagawa Cancer Center
  • Miyagi, Sendai, Japan, 980-8574
    • Tohoku University Hospital
  • Okayama, Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Tokyo, Chuo-ku, Japan, 104-0045
    • National Cancer Center Hospital
• Norway
  • Oslo, Norway, N-0379
    • Oslo Universitetssykehus HF, Radiumhospitalet
• Poland
  • Warsaw, Poland, 02-781
    • Oncology Center-Maria Sklodowska-Curie Institute
• Spain
  • Aragon, Spain, 50009
    • Hospital Universitario Miguel Servet
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Hospital Universitario HM Sanchinarro
  • Santiago de Compostela, Spain, 15706
    • Hospital Clínico de Santiago
• Sweden
  • Stockholm, Sweden, SE-171 76
    • Karolinska Comprehensive Cancer Center
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden Hospital, Chelsea
  • London, United Kingdom, NW12PQ
    • University College Hospital
• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Precision NextGen Oncology
    • Santa Monica, California, United States, 90403
      • Sarcoma Oncology Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale Cancer Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Cancer Center
  • Missouri
    • St Louis, Missouri, United States, 63108
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists-Omaha-69066
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center & Research Institute
    • Nashville, Tennessee, United States, 37232
      • Henry-Joyce Cancer Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brigimadlin	Drug: Brigimadlin; Brigimadlin; Other Names: BI 907828

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint will be the occurrence of treatment-emergent adverse events (AEs) according to CTCAE Version 5.0 during the entire treatment period	CTCAE=Common Terminology Criteria for Adverse Events	up to 9 years.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; brigimadlin
• Other Study ID Numbers: 1403-0032; 2024-514177-21-00 (Registry Identifier: CTIS); U1111-1305-3484 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No