DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 764532: BI 764532
Carboplatin: Standard of care
Etoposide: Standard of care
Cisplatin: Standard of care
Study summary
This study is open to adults aged 18 and older or above legal age who have a specific type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker called DLL3.
The purpose of this study is to test a medicine called BI 764532 in addition to chemotherapy. The study has Part A1, Part A2, and Part B. Part A1 of this study aims to find out the highest dose of BI 764532 that people can tolerate in addition to chemotherapy. Part A2 of this study is to find out how well people tolerate a low dose of BI 764532 combined with the chemotherapy. The purpose of Part B is to find out how well people can tolerate BI 764532 in combination with different chemotherapies. Researchers also want to find out whether BI 764532 in combination with chemotherapy helps people with NEC.
Participants get different doses of BI 764532 as an infusion into a vein. In addition, they get platinum-based chemotherapy as infusions into a vein. Participants can continue treatment up to 3 years if they benefit from treatment and can tolerate it.
Participants visit their doctors regularly. During these visits, the doctors collect information about participants' health and take note of any unwanted effects. Doctors also regularly check the size of the tumour.
Eligibility
Primary outcome measure(s)
- Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period — Up to 21 days.
- Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period — Up to 36 months.
- Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period — Up to 36 months.
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Miami | Miami | Florida | |
| Winship Cancer Institute | Atlanta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| John Theurer Cancer Center | Hackensack | New Jersey | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | |
| Hopital Louis Pradel | Bron | France | |
| INS Paoli-Calmettes | Marseille | France | |
| Klinikum der Universität München AÖR | München | Germany | |
| Universitätsklinikum Tübingen | Tübingen | Germany | |
| Aichi Cancer Center Hospital | Aichi, Nagoya | Japan | |
| National Cancer Center Hospital East | Chiba, Kashiwa | Japan | |
| Osaka International Cancer Institute | Osaka, Osaka | Japan | |
| National Cancer Center Hospital | Tokyo, Chuo-ku | Japan | |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| Hospital Universitario La Paz | Madrid | Spain | |
| Sahlgrenska Universitetsjukhuset | Gothenburg | Sweden | |
| Uppsala University Hospital | Uppsala | Sweden |
More Boehringer Ingelheim trials in the Netherlands
Other trials for the same condition
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 NCT06132113 on ClinicalTrials.gov ↗ ← All trials in the Netherlands