Find the safe dose for BI 891065 alone and in combo with BI 754091

• Research type

  Research Study

• Full title

  An open-label Phase I dose finding trial with BI 891065 alone and in combination with BI 754091 to characterise safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in patients with advanced and/or metastatic malignancies

• IRAS ID

  275204

• Contact name

  Colin Lindsay

• Contact email

  colin.lindsay@christie.nhs.uk

• Sponsor organisation

  Boehringer Ingelheim Limited

• Eudract number

  2017-000465-74

• Clinicaltrials.gov Identifier

  NCT03166631

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 6 months, 2 days

• Research summary

  This study will test the investigational drug, BI 891065 (study drug), for the first time. "Investigational" means that the study drug being tested is not approved for any disease by the Medicines and Healthcare Products Regulatory Agency (MHRA) for use outside of research studies. BI 891065 will be tested by itself and in combination with another investigational study drug, BI 754091. BI 754091 is presently being tested in another study in patients with advanced cancers.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  20/EE/0006

• Date of REC Opinion

  24 Apr 2020

• REC opinion

  Further Information Favourable Opinion