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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
NCT06132113 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Etoposide
- DRUG BI 764532
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc — Brussels
- HOP Louis Pradel — Bron
- INS Paoli-Calmettes — Marseille
- Klinikum der Universität München AÖR — München
- Universitätsklinikum Tübingen — Tübingen
- Aichi Cancer Center Hospital — Aichi, Nagoya
- National Cancer Center Hospital East — Chiba, Kashiwa
- Osaka International Cancer Institute — Osaka, Osaka
- National Cancer Center Hospital — Tokyo, Chuo-ku
- Universitair Medisch Centrum Groningen — Groningen
- Hospital Universitari Vall D Hebron — Barcelona
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario La Paz — Madrid
- Sahlgrenska Universitetsjukhuset — Gothenburg
- Akademiska hospital — Uppsala
Florida
- University of Miami — Miami
Georgia
- Winship Cancer Institute — Atlanta
Illinois
- Northwestern University — Chicago
New Jersey
- John Theurer Cancer Center — Hackensack
Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2024-01-22 |
| Est. Completion | 2027-04-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06132113
The ClinicalTrials.gov registry entry for NCT06132113 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neuroendocrine Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06132113 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06132113 about?
NCT06132113 is a clinical study titled "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". 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 Pa...
What is the current status of trial NCT06132113?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2024-01-22. Estimated completion is 2027-04-25.
What conditions does trial NCT06132113 study?
This clinical trial studies the following conditions: Neuroendocrine Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06132113?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Etoposide (DRUG), BI 764532 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06132113?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06132113 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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