Status:
COMPLETED
Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Liposarcoma, Dedifferentiated
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2. The purpose of this study is to find out...
Eligibility Criteria
Inclusion
- 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 (ICH) - Good Clinical Practice (GCP) and local legislation prior to any study-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 two 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 study 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
- Histologically documented locally advanced or metastatic, unresectable (i.e. surgery morbidity would outweigh potential benefits), progressive or recurrent Dedifferentiated liposarcoma (DDLPS), meeting the criteria for an open study cohort:
- Cohort A: patient has not received prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
- Cohort B: patient has received any prior systemic therapy for DDLPS in any setting (including adjuvant, neoadjuvant, maintenance, palliative)
- Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridisation (FISH) or next-generation sequencing (NGS)
- Presence of at least 1 measurable target lesion according to RECIST version 1.1. In patients who only have 1 target lesion, the baseline imaging must be performed at least 2 weeks after any biopsy of the target lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥3 months at the start of treatment in the opinion of the investigator Further inclusion criteria apply.
Exclusion
- Known mutation in the TP53 gene (screening for TP53 status is not required)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment or planned within 6 months after screening
- Previous administration of brigimadlin or any other MDM2-p53 or MDM4 regulator of p53 (MDM4/MDMX)-p53 antagonist
- Previous treatment in study 1403-0008 (Brightline-1)
- Having to receive, or intending to receive, restricted medications or any drug considered likely to interfere with the safe conduct of the study
- Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or endpoint assessment
- Unable to swallow the study treatment
- Previous or concomitant malignancies other than the one treated in this study within the previous 2 years, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other malignancy that is considered cured by local treatment Further exclusion criteria apply.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06058793
Start Date
December 13 2023
End Date
December 12 2025
Last Update
January 9 2026
Active Locations (56)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Mayo Clinic-Arizona
Phoenix, Arizona, United States, 85054
3
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
4
Sarcoma Oncology Center
Santa Monica, California, United States, 90403