🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05916313
Recruiting Phase 1

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

NCT05916313 · tracked via the Priya Life Science USA tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 1
Started
2024-01-30
Last updated
2026-08-11

Condition(s) studied

Glioma

Investigational drug(s) / intervention(s)

BI 764532

BI 764532: BI 764532

Study summary

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 a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is continued. During this time, participants visit the study site at regular intervals. The total number of visits depends on how they respond to and tolerate the treatment. The first study visits include staying to monitor participants' safety. Doctors record any unwanted effects and regularly check the general health of the participants.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
University of California Irvine Orange California Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Salzburg Cancer Research Institute Salzburg Austria Recruiting
Universitätsklinikum Frankfurt Frankfurt Germany Recruiting
Klinikum der Universität München AÖR München Germany Completed
Universitätsklinikum Tübingen Tübingen Germany 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

More Boehringer Ingelheim trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05916313 on ClinicalTrials.gov ↗ ← All trials in the USA