Title
Brightline-2: A Phase IIa/IIb, Open-Label, Single-Arm, Multi-Centre Trial of brigimadlin (BI 907828) for Treatment of Patients With Locally Advanced / Metastatic, MDM2 Amplified, TP53 Wild-Type Biliary Tract Adenocarcinoma, Pancreatic Ductal Adenocarcinoma, or Other Selected Solid Tumours

Description
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists.

The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

Objective
Cohort 1 (biliary tract adenocarcinoma):
-The primary objective is to evaluate the efficacy of BI 907828 by the proportion of patients with objective response (OR).
-Secondary objectives are to evaluate the efficacy of BI 907828 by median estimate of duration of objective response (DOR), progression-free survival (PFS), and overall survival (OS) as well as the assessment of health-related quality of life as assessed by the EORTC QLQ-C30 and the EORTC QLQ-BIL21.

Cohort 2 (pancreatic ductal adenocarcinoma):
-The primary objective is to evaluate the efficacy of BI 907828 by the proportion of patients with OR.
-Secondary objectives are to evaluate the efficacy of BI 907828 by median estimate of DOR, PFS, and OS.

Treatment Experimental: BI 907828 treatment arm
Drug: BI 907828
BI 907828

Key Eligibility For full study eligibility, see this study's clinicaltrials.gov record.

Applicable Disease Sites
Bladder; Liver; Lung; Prostate

Participating Institutions
UW Health University Hospital