This study is open to adults with small cell lung cancer and other neuroendocrine cancers that are positive for the tumour marker delta-like 3 (DLL3). The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out the highest dose of BI 764532 and the best treatment schedule that people can tolerate. BI 764532 is an antibody-like molecule (DLL3/CD3 bispecific) that may help the immune system fight cancer. In this study, BI 764532 is given to people for the first time. That means no clinical data are available for BI 764532. Participants get BI 764532 either weekly or once every 3 weeks. If there is benefit for the participants and if they can tolerate it, the treatment is given for a maximum of 3 years. During this time, participants visit the study site about 20 times depending on the response to the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
BI 764532 - parenteral 1
BI 764532 - parenteral 2
Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGUniversity of Maryland School of Medicine
Baltimore, Maryland, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
COMPLETEDUniversitätsklinikum Köln (AöR)
Cologne, Germany
RECRUITINGTechnische Universität Dresden
Dresden, Germany
RECRUITINGUniversitätsklinikum Würzburg AÖR
Würzburg, Germany
RECRUITINGNational Cancer Center Hospital East
Chiba, Kashiwa, Japan
RECRUITINGHospital del Mar
Barcelona, Spain
RECRUITINGHospital Universitari Vall D Hebron
Barcelona, Spain
RECRUITING...and 2 more locations
Arm 1 and Arm 2: Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal or above 33% during the MTD evaluation period. Separate MTDs will be determined for each Regimen.
Time frame: up to 36 months
Arm 1 and Arm 2: Number of patients with DLTs in the MTD evaluation period
Time frame: up to 36 months
Arm 1 and Arm 2: Maximum measured concentration (Cmax) of BI 764532
Time frame: up to 36 months
Arm 1 and Arm 2: Area under the concentration-time curve (AUCτ) of the analyte over a uniform dosing interval τ
Time frame: up to 36 months
Arm 1 and Arm 2: Objective response based on RECIST 1.1 criteria in patients with measurable disease
Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with measurable disease
Time frame: up to 36 months
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