Actively Recruiting
DAREON1-7: A Phase I Trial to Investigate Safety and Tolerability of BI 764532 Infusions with Standard Chemotherapy in First-line Treatment of Neuroendocrine Carcinomas
Led by Boehringer Ingelheim · Updated on 2026-05-27
55
Participants Needed
20
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of the medicine BI 764532 combined with chemotherapy in adults aged 18 and older who have advanced neuroendocrine cancer (NEC) with tumours positive for the DLL3 marker. This phase 1 trial includes several parts to determine the highest tolerated dose and how well patients tolerate different doses of BI 764532 alongside standard chemotherapy. The study aims to understand if this combination helps people with NEC. Participants receive BI 764532 through intravenous infusions at varying doses, along with platinum-based chemotherapy drugs such as carboplatin, cisplatin, and etoposide, also given by infusion. The study includes Part A1 to test dose escalation, Part A2 to assess tolerance to a low dose, and Part B to evaluate BI 764532 with different chemotherapy combinations. Treatment can continue for up to three years if it benefits the participant and is tolerated. Throughout the study, participants visit their doctors regularly for health monitoring and to report any side effects. Doctors measure tumour size and collect safety data, including the occurrence of dose-limiting toxicities over treatment periods ranging from up to 21 days to 36 months. The study tracks response to treatment, duration of response, and adverse events. Monitoring helps ensure participant safety and gathers detailed information on how well the treatment is tolerated over time.
CONDITIONS
Brief 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 aged 18 years or older and at least the legal age of consent
- Signed informed consent before any trial procedures
- Diagnosed with locally advanced or metastatic neuroendocrine carcinoma (NEC) of specified subtypes
- Tumours with mixed histologies eligible if neuroendocrine carcinoma component is predominant (at least 50%)
- ECOG performance status of 0 or 1
- Minimum life expectancy of 12 weeks
- At least one measurable lesion as defined by RECIST 1.1 within about 35 days prior to first dose
- Patients with history of asymptomatic CNS metastases eligible if stable and off steroids or anti-convulsants for at least 7 days
You will not qualify if you...
- Previous treatment in this trial
- Current enrollment in another investigational drug or device trial or less than 30 days since ending such trials
- Diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma, or Grade 3 neuroendocrine tumour
- Presence of leptomeningeal carcinomatosis
- Prior treatment with DLL3-targeting T cell engagers and cell therapies
- Extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration
- Major surgery within 28 days prior to first administration or planned during treatment
- Active or suspected malignancy or history of malignancy within 5 years prior to screening, except certain treated skin or cervical cancers
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive infusions of BI 764532 in addition to chemotherapy with carboplatin and etoposide or cisplatin and etoposide as first-line treatment for neuroendocrine carcinomas. The treatment includes different dose levels of BI 764532 depending on the study part.
Visits occur regularly during treatment for monitoring and administration
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
Active, Not Recruiting
12
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Active, Not Recruiting
13
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Active, Not Recruiting
14
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Active, Not 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
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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