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Brightline-4: A study to test how well brigimadlin is tolerated by people with a type of cancer called dedifferentiated liposarcoma
EU CTIS ID: 2023-504522-19-00
What this study is testing
The primary objective of the study is to evaluate the safety of brigimadlin in patients with advanced or metastatic DDLPS by assessing the incidence of treatment-emergent adverse events (TEAEs) and to characterise the severity, frequency, seriousness, relationship, and outcome of TEAEs. Intercurrent event handling strategies will be applied.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)1 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 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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)1 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 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 criteria apply.
What rules you out
- 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 criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Australia
- Argentina
- United Kingdom
- Canada
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Australia; Argentina; United Kingdom; Canada; Brazil and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.