1403-0002 Study of BI products in in patients with advanced solid tumors

• Research type

  Research Study

• Full title

  A phase Ia/Ib, open label, dose-escalation study of the combination of BI 907828 with BI 754091 (ezabenlimab) and BI 754111 and the combination of BI 907828 with BI 754091(ezabenlimab) followed by expansion cohorts, in patients with advanced solid tumors

• IRAS ID

  1005475

• Contact name

  Medical Information

• Contact email

  medinfo.bra@boehringer-ingelheim.com

• Sponsor organisation

  Boehringer Ingelheim Ltd.

• Eudract number

  2019-001173-84

• Clinicaltrials.gov Identifier

  NCT03964233

• Research summary

  This study has 2 parts. The first part of the study is done. The first part was open to adults
  with different types of advanced cancer (solid tumors). The second part is open to people
  with specific types of soft tissue sarcoma, advanced lung cancer, and cancer in the stomach,
  bladder or bile ducts.
  The participants get a combination of 2 medicines called brigimadlin (also called BI 907828)
  and ezabenlimab (also called BI 754091). Brigimadlin is a so-called MDM2 inhibitor that is
  being developed to treat cancer. Ezabenlimab is an antibody that may help the immune
  system fight cancer (immune checkpoint inhibitor). When the study started, some
  participants got a third medicine called BI 754111 in addition. Treatment with BI 754111
  was stopped because data from another study showed no additional effect of BI 754111.
  The purpose of the first part of the study was to find out the highest dose of brigimadlin that
  the participants could tolerate in combination with ezabenlimab. This dose is used in the
  second part of the study.
  The purpose of the second part is to see whether the combination of brigimadlin with
  ezabenlimab is able to make tumors shrink.
  The participants are in the study as long as they benefit from treatment and can tolerate it.
  Ezabenlimab treatment is limited to 2 years. During this time, they get infusions of
  ezabenlimab, and take tablets with brigimadlin every 3 weeks. The doctors check how many
  participants have health problems during the study. The doctors also monitor the size of the
  tumor

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  22/SC/0206

• Date of REC Opinion

  19 Jul 2022

• REC opinion

  Further Information Favourable Opinion