Brightline-4: A Phase III Open-label, Single-arm, Multi-center Study to Assess the Safety and Efficacy of Brigimadlin (BI 907828) Treatment in Patients With Treatment-naïve or Pre-treated Advanced Dedifferentiated Liposarcoma

1. 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)
2. 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)
3. Measureable disease
4. ECOG PS 0-1
5. No known mutation in TP53
6. No prior MDM2 inhibitor
7. No prior or concomittant cancers within 2 years except non-melanoma skin cancers, or other treatment curative by local therapy only

• Primary
  • AEs
  • Grade 3 or higher AEs
• Secondary
  • SAEs
  • AE leading to study discontinuation, dose reduction, or dose delay
  • AEs of special interest
  • ORR
  • PFS
  • OS
  • DOR
  • DCR