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
Rekrutierend
NCT-Nummer:
NCT05916313
Studienbeginn:
Dezember 2023
Letztes Update:
06.08.2024
Wirkstoff:
BI 764532
Indikation (Clinical Trials):
Glioma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Boehringer Ingelheim
Collaborator:
-
Kontakt
Boehringer Ingelheim
Kontakt:
Phone: 1-800-243-0127
E-Mail: clintriage.rdg@boehringer-ingelheim.com» Kontaktdaten anzeigen
Brief 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.
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:
1. Part A: Occurrence of dose-limiting toxicity (DLT) during the maximum tolerated dose (MTD) evaluation period (Time Frame - up to 4 weeks)
2. Part B: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period (Time Frame - up to 14 months)
Secondary outcome:
1. Part A: Occurrence of dose-limiting toxicity (DLT) during the entire treatment period (Time Frame - up to 26 months)
- Experimental: BI 764532: Part A - Dose escalation cohort
- Experimental: BI 764532: Part B - Dose expansion cohort
Quelle: ClinicalTrials.gov
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