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
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Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
* 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
You may not be if
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
Clareo Health | 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
