1403-0011: A study to assess the efficacy, safety and tolerability of brigimadlin

• Research type

  Research Study

• Full 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

• IRAS ID

  1007927

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Limited

• Eudract number

  2022-001500-18

• Clinicaltrials.gov Identifier

  NCT05512377

• Research summary

  Lay Title
  A study to test whether brigimadlin (BI 907828) helps people with cancer in the biliary tract, pancreas, lung, or bladder

  Brief Summary
  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 brigimadlin (BI 907828) helps people with cancer in the biliary tract, pancreas, lung or bladder. Brigimadlin is a MDM2-p53 antagonist that is being developed to treat cancer. All participants take brigimadlin as a tablet once every 3 weeks. Participants may continue to take brigimadlin 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.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  23/SC/0279

• Date of REC Opinion

  17 Oct 2023

• REC opinion

  Further Information Favourable Opinion