FIH trial of BI1703880, a non-CDN STING agonist in combination with ezabenlimab

  • Research type

    Research Study

  • Full title

    Phase Ia, first in human open label dose escalation trial evaluating intravenous BI 1703880 in combination with intravenous ezabenlimab for treatment of advanced solid tumours

  • IRAS ID

    1006124

  • Contact name

    Medical Information N/A

  • Contact email

    medinfo.bra@boehringer-ingelheim.com

  • Sponsor organisation

    Boehringer Ingelheim Limited

  • Eudract number

    2022-000298-22

  • Clinicaltrials.gov Identifier

    NCT05471856

  • Research summary

    This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists.
    The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time.
    Participants get BI 1703880 and ezabenlimab as infusions into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks.
    Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants’ health and take note of any unwanted effects.

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference

    22/YH/0255

  • Date of REC Opinion

    1 Dec 2022

  • REC opinion

    Further Information Favourable Opinion