Actively Recruiting
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
Led by Boehringer Ingelheim · Updated on 2026-05-12
55
Participants Needed
20
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants 18 years or older and at least the legal age of consent
- Signed informed consent before any study procedures
- Diagnosed with locally advanced or metastatic neuroendocrine carcinoma (extrapulmonary, pulmonary large cell, or unknown primary site)
- Tumors with mixed histology eligible if neuroendocrine carcinoma component is predominant (at least 50%)
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion per RECIST 1.1 within 35 days before first dose
- History of asymptomatic CNS metastases allowed if stable without recent radiotherapy or steroids
You will not qualify if you...
- Previous treatment in this trial
- Current enrollment in another investigational device or drug trial or ended one less than 30 days ago
- Diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma, or Grade 3 neuroendocrine tumor
- Presence of leptomeningeal carcinomatosis
- Prior treatment with DLL3-targeting T cell engagers or cell therapies
- Extensive field radiotherapy including whole brain irradiation within 2 weeks before first dose
- Major surgery within 28 days before first dose or planned during treatment
- Active or suspected malignancy within 5 years prior to screening except target indication or certain treated skin or cervical cancers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
4
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
7
Hôpital Louis Pradel
Bron, France, 69500
Not Yet Recruiting
8
INS Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
9
Klinikum der Universität München AÖR
München, Germany, 81377
Not Yet Recruiting
10
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
11
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Actively Recruiting
12
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Actively Recruiting
13
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
14
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Actively Recruiting
15
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
16
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
17
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
18
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
19
Sahlgrenska Universitetsjukhuset
Gothenburg, Sweden, 413 46
Actively Recruiting
20
Uppsala University Hospital
Uppsala, Sweden, 751 85
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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