A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3

This study (1438-0003) is open to adults with a tumour in the brain that is positive for the tumour marker delta-like 3 (DLL3). This study is in people with advanced cancer for whom previous treatment was not successful. The purpose of this study is to find out the highest dose of BI 764532 that people with a brain tumour that is positive for DLL3 can tolerate. BI 764532 is an antibody-like molecule that can attach and link together the cancer cells and T-cells of the immune system (DLL3/CD3 bispecific). This may help the immune system fight cancer. Participants get BI 764532 infusions into

Trial Details

NCT ID
NCT05916313
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • BI 764532
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Salzburg, Austria|47.79941,13.04399
  • Frankfurt, Germany|49.68333,10.53333
  • München, Germany|51.60698,13.31243

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 (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GC…
  • Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
  • Availability of archival tumour tissue for Delta-like 3 (DLL3) expression by central assessment.

For full eligibility, visit ClinicalTrials.gov.

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