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)
DAREON™-7: A Phase I, Open-label, Dose Escalation and Expansion Trial to Investigate Safety and Tolerability of BI 764532 Intravenous Infusions in Combination With Standard of Care (Platinum and Etoposide) in First-line Treatment of Patients With Neuroendocrine Carcinomas (NEC)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (8 items).
Location: University of Miami — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Previous treatment in this trial
- Current enrolment in another investigational device or drug trial, or \<30 days since ending another investigational device or drug trial(s)
- Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma or Grade 3 neuroendocrine tumour
- Presence of leptomeningeal carcinomatosis
- Previous treatment with DLL3-targeting T cell engagers and cell therapies
- Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532
- Major surgery (major according to the investigator's assessment) within 28 days prior to first administration of BI 764532 or planned during treatment period, e.g. hip replacement Any documented active or suspected malignancy or history of malignancy within 5 years prior to Screening (other than the target indication or well differentiated neuroendocrine tumour (NET) stages of the target indication in case of transformed tumors), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (21 Sites)
- 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,
- Universitair Ziekenhuis Antwerpen — Edegem,
- Hôpital 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,
- Uppsala University Hospital — Uppsala,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Neuroendocrine Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.