DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers

This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. The study

Trial Details

NCT ID
NCT05882058
Phase
PHASE2
Sponsor
Boehringer Ingelheim
Status
RECRUITING
Cancer Type
Small Cell (SCLC) Lung Cancer
Interventions
  • BI 764532, dose 1
  • BI 764532, dose 2
  • Ventana DLL3 RxDx assay
Locations (sample)
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Los Angeles, California, United States|34.05223,-118.24368
  • San Francisco, California, United States|37.77493,-122.41942
  • Jacksonville, Florida, United States|30.33218,-81.65565

Key Eligibility Criteria

  • Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of si…
  • Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local leg…
  • Part 1: Histologically or cytologically confirmed, cancer of the following histologies:
  • Small cell lung cancer (SCLC)

For full eligibility, visit ClinicalTrials.gov.

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