epNEC (except for MCC,MTC,Grade 3 neuroendocrine tumour) LCNEC NEC of unknown primary site
Conditions
Interventions
Sponsors
Imazu Susumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female participants >=18 years old and over 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 percent 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 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 - Are neurologically stable without the need for steroids or anti-convulsants for at least 7 days before first dose of BI 764532 as per local site assessment Further inclusion criteria apply.
Exclusion criteria
Exclusion criteria: - Previous treatment in this trial - Current enrolment in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) - Patients with diagnosis of Merkel cell carcinoma (MCC) or medullary thyroid carcinoma (MTC) 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 1 week 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), except for appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix Further exclusion criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A : the occurrence of DLTs in the MTD evaluation period Part B : the occurrence of DLTs during the on-treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: - Occurrence of DLTs during the on-treatment period - Occurrence of AEs during the on-treatment period Part B: - Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 (based on investigator's assessment) from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent - Duration of response (DoR), defined as the time from first documented confirmed objective response (OR) until the earliest date of disease progression or death among patients with confirmed objective response | — |
Countries
Belgium, France, Germany, Japan, Netherlands, Spain, Sweden, United States
Contacts
Public ContactNobuko Yamada
Boehringer Ingelheim
Outcome results
None listed