Testing a new treatment for brain tumors positive for DLL3

A Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3

This study is testing a new treatment for adults with advanced glioma that has the DLL3 marker to see if a special antibody can help their immune system fight the tumor better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Drugs / interventions: bevacizumab, chemotherapy, radiation
• Locations: 12 sites (Orange, California and 11 other locations)
• Trial ID: NCT05916313 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed progressive glioma that is DLL3 positive and has failed standard therapies.

Not a fit: Patients with gliomas that do not express DLL3 or those who have not progressed after standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced glioma who have limited treatment choices.

How similar studies have performed: While this approach is novel in targeting DLL3 in gliomas, similar bispecific antibody strategies have shown promise in other cancers.

Eligibility criteria

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 by central assessment.
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 this trial is running

Orange, California and 11 other locations

• 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 am Main, Germany (Recruiting)
• Klinikum der Universität München AÖR — München, Germany (Recruiting)
• Universitätsklinikum Tübingen — Tübingen, Germany (Not_yet_recruiting)
• Erasmus Medisch Centrum-ROTTERDAM-50697 — Rotterdam, Netherlands (Recruiting)
• Hospital del Mar — Barcelona, Spain (Recruiting)
• Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
• Cantonal Hospital of Aarau — Aarau, Switzerland (Recruiting)
• University Hospital of Lausanne — Lausanne, Switzerland (Recruiting)
• University Hosp. Zurich — Zurich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Glioma