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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
BI 764532
Standard of care
Standard of care
Standard of care
University of Miami
Miami, Florida, United States
RECRUITINGWinship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
NOT_YET_RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGCliniques Universitaires Saint-Luc
Brussels, Belgium
RECRUITINGHOP Louis Pradel
Bron, France
NOT_YET_RECRUITINGINS Paoli-Calmettes
Marseille, France
RECRUITINGKlinikum der Universität München AÖR
München, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Tübingen
Tübingen, Germany
RECRUITING...and 10 more locations
Part A1: Occurrence of dose-limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: Up to 21 days.
Part A2: Reduced monitoring: the occurrence of DLTs during the on-treatment period
Time frame: Up to 36 months.
Part B: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Time frame: Up to 36 months.
Part A1: Occurrence of dose-limiting toxicities (DLTs) during the on-treatment period
Time frame: Up to 36 months.
Part A1: Occurrence of adverse events (AEs) during the on-treatment period
Time frame: Up to 36 months.
Part A2: Occurrence of adverse events (AEs) during the on-treatment period
Time frame: Up to 36 months.
Part A2: Objective response (OR)
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.
Time frame: Up to 36 months.
Part B: Objective response (OR)
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.
Time frame: Up to 36 months.
Part B: Duration of response (DoR)
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.
Time frame: Up to 36 months.
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