B-I Brightline-4 / 1403-0019

Official Title

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

 

Study Purpose

The primary objective is to evaluate the safety of brigimadlin in patients with advanced or metastatic DDLPS

The secondary objectives are to evaluate efficacy by using objective response (OR), duration of objective response (DOR), PFS, and overall survival (OS), and to further assess safety.

Diagnosis

Patients with histologically proven locally advanced or metastatic, unresectable, progressive or recurrent dedifferentiated liposarcoma

Eligibility

Patients with histologically proven locally advanced or metastatic, unresectable, progressive or recurrent dedifferentiated liposarcoma including those patients who have not received any prior systemic therapy. Cannot have a known mutation in the TP53 gene

Intervention

Brigimadlin (BI 907828)

Oral, single 45 mg dose, on Day 1 q3w