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DAREON™-7: BI 764532 with Chemotherapy for Advanced Neuroendocrine Cancers

This study, DAREON™-7, is for adults aged 18 and older with advanced neuroendocrine cancer (NEC) whose tumors have a specific marker called DLL3. It is testing different doses of a drug called BI 764532 when given along with standard chemotherapy (Carboplatin, Etoposide, or Cisplatin). The main goal is to find out how well people tolerate BI 764532 at various doses and in combination with different chemotherapies. Researchers also want to see if this combination helps people with NEC. The study plans to enroll 65 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 65 participants. It aims to find the highest tolerable dose of BI 764532 with chemotherapy, and then assess tolerance at a lower dose and with different chemotherapies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for dose-limiting toxicities (side effects that are severe enough to limit the dose of treatment) for up to 36 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06132113

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~65 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:BI 764532CarboplatinEtoposideCisplatin

At a glance

Recruiting sites
0 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Measured over Up to 21 days.
+2 more outcomes measured

Conditions

Neuroendocrine Neoplasms

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Neuroendocrine Carcinoma

NCT06132113

Where you'd take part

This study runs at 21 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, Japanno site contact published

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgiumno site contact published

  • Hopital Louis Pradel

    Bron, Franceno site contact published

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainno site contact published

  • Hospital Universitario 12 de Octubre

    Madrid, Spainno site contact published

  • Hospital Universitario La Paz

    Madrid, Spainno site contact published

  • INS Paoli-Calmettes

    Marseille, Franceno site contact published

  • John Theurer Cancer Center

    Hackensack, New Jerseyno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF)
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
Patients diagnosed with locally advanced or metastatic NEC of following subtypes:
extrapulmonary neuroendocrine carcinomas (epNEC)
pulmonary large cell NEC (LCNEC)
neuroendocrine carcinomas (NEC) of unknown primary site
Patients with tumours with mixed histologies for any above type are eligible only if neuroendocrine carcinoma/small tumour cells component is predominant and represent at least 50% of the overall tumour tissue
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Minimum life expectancy of 12 weeks
At least one measurable lesion as defined per RECIST 1.1 within approximately 35 days prior to the first dose of BI 764532
Patients with a history of asymptomatic Central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria:
No radiotherapy (including whole brain radiation therapy, stereotactic radiotherapy or radiosurgery) within 7 days

Exclusion

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

What this trial measures

  • Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation periodUp to 21 days.
  • Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment periodUp to 36 months.
  • Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment periodUp to 36 months.