Trial Title:
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
NCT ID:
NCT05916313
Condition:
Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI 764532
Description:
BI 764532
Arm group label:
BI 764532: Part A - Dose escalation cohort
Arm group label:
BI 764532: Part B - Dose expansion cohort
Other name:
Obrixtamig
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Salzburg Cancer Research Institute
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800017900
Email:
oesterreich@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Frankfurt
Address:
City:
Frankfurt am Main
Zip:
60528
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Klinikum der Universität München AÖR
Address:
City:
München
Zip:
81377
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Universitätsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08007234742
Email:
deutschland@bitrialsupport.com
Facility:
Name:
Erasmus Medisch Centrum
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
08000204613
Email:
nederland@bitrialsupport.com
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Cantonal Hospital of Aarau
Address:
City:
Aarau
Zip:
CH-5001
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Facility:
Name:
University Hospital of Lausanne
Address:
City:
Lausanne
Zip:
1101
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Facility:
Name:
University Hosp. Zurich, Dept. of Neurology, Stroke Center
Address:
City:
Zurich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0800005900
Email:
suisse@bitrialsupport.com
Start date:
December 13, 2023
Completion date:
August 17, 2026
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05916313
http://www.mystudywindow.com
