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

NCT06619509 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 1403-00322024-514177-21-00U1111-1305-3484
• Study Type: interventional
• Target: 90
• Locations: 20 countries
• Sites: 50

Brief Summary

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.

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Brigimadlin

EXPERIMENTAL

Drug: Brigimadlin

Interventions

Brigimadlin DRUG

Brigimadlin

Also known as: BI 907828

Brigimadlin

Eligibility Criteria

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

You may qualify if:

• Patient is ongoing on brigimadlin treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial').
• 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.
• 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.
• Participants must be willing and able to comply with the scheduled visits, treatment plan, lifestyle, laboratory tests, contraceptive guidelines, and other study procedures.
• Adequate organ function.
• 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.

You may not qualify if:

• Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with brigimadlin.
• Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
• 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.
• Patient has unacceptable toxicity on brigimadlin at the time of transition into this trial.
• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (50)

Precision NextGen Oncology

Beverly Hills, California, 90212, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06511, United States

Location

Mayo Clinic Cancer Center

Jacksonville, Florida, 32224, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Nebraska Cancer Specialists-Omaha-69066

Omaha, Nebraska, 68130, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

West Cancer Center & Research Institute

Germantown, Tennessee, 38138, United States

Location

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Utah Cancer Specialists Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Sanatorio Finochietto

CABA, C1120AAB, Argentina

Location

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, 2031, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Arthur J. E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Sun Yat-Sen University Cancer Center

Guangzhou, 510060, China

Location

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

Copenhagen University Hospital, Rigshospitalet

København Ø, 2100, Denmark

Location

CTR Leon Berard

Lyon, 69373, France

Location

CTR Eugène Marquis

Rennes, 35042, France

Location

Helios Klinikum Berlin-Buch

Berlin, 13125, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Clinexpert Gyongyos

Gyöngyös, 3200, Hungary

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Istituto Oncologico Veneto IRCCS

Padova, 35128, Italy

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

Location

Kanagawa Cancer Center

Kanagawa, Yokohama, 241-8515, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Okayama University Hospital

Okayama, Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

Location

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, N-0379, Norway

Location

Oncology Center-Maria Sklodowska-Curie Institute

Warsaw, 02-781, Poland

Location

Hospital Universitario Miguel Servet

Aragon, 50009, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Hospital Clínico de Santiago

Santiago de Compostela, 15706, Spain

Location

Karolinska Comprehensive Cancer Center

Stockholm, SE-171 76, Sweden

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

University College Hospital

London, NW12PQ, United Kingdom

Location

The Royal Marsden Hospital, London

London, SW3 6JJ, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Interventions

brigimadlin

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: September 27, 2024
• First Posted: October 1, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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

BE (2); DE (2); PL (1); CN (1); JP (7); IL (1); NO (1); TW (1); CA (2); US (13); HU (1); FR (2); IT (2); AU (2); DK (1); ES (5); SE (1); AR (1); GB (3); CZ (1)