Testing a new treatment for brain tumors positive for DLL3

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is focused on adults with advanced glioma that expresses the DLL3 tumor marker, who have not responded to previous treatments. It aims to determine the highest tolerable dose of BI 764532, a bispecific antibody that links cancer cells to T-cells, potentially enhancing the immune response against the tumor. Participants will receive infusions of BI 764532 and will be monitored for safety and treatment response during regular visits to the study site. The study is designed to assess both the tolerability and efficacy of the treatment in this specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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 signature of the first informed consent form (ICF1).
2. Signed and dated written informed consent (ICF1 and ICF2) in accordance with International Council for Harmonisation-Good clinical practice (ICH-GCP) and local legislation prior to admission to the trial.
3. Patients with histologically confirmed primary progressive diffuse glioma who have failed standard of care therapies.
4. Availability of archival tumour tissue for Delta-like 3 (DLL3) expression.
5. Tumours must be positive for DLL3 expression by immunohistochemistry (IHC) on archived tumour tissue according to central pathology review.
6. Documented unequivocal progression after radiotherapy and/or chemotherapy with measurable disease by response assessment in neuro-oncology (RANO) criteria.
7. Karnofsky performance score ≥70. Further inclusion criteria apply.

Exclusion Criteria:

1. Previous treatment in this trial.
2. Current enrolment in another investigational device or drug trial.
3. Presence of extracranial metastatic or leptomeningeal disease.
4. Previous treatment with therapies targeting DLL3.
5. Prior treatment with bevacizumab or other anti-vascular endothelial growth factor (anti-VEGF) or anti-angiogenic treatment within 6 months prior to first administration of BI 764532.
6. Recent anti-cancer therapy: treatment with any other anticancer drug within 21 days or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.
7. Radiotherapy within the 3 months prior to the diagnosis of progression; unless tumour progression is clearly outside the radiation field or tumour progression is unequivocally proven by surgery/biopsy.

Further exclusion criteria apply.

Where it's running

• University of California Irvine
  Orange, California, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Salzburg Cancer Research Institute
  Salzburg, Austria Recruiting
• Universitätsklinikum Frankfurt
  Frankfurt, Germany Recruiting
• Erasmus Medisch Centrum-ROTTERDAM-50697
  Rotterdam, Netherlands Recruiting
• Hospital del Mar
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.