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A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3
Sponsor: Boehringer Ingelheim
Summary
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.
Official title: A First-In-human Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 764532 Administered by Parenteral Route in Patients With Small Cell Lung Carcinoma and Other Neuroendocrine Neoplasms Expressing DLL3
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2020-07-29
Completion Date
2027-02-15
Last Updated
2025-12-10
Healthy Volunteers
No
Interventions
BI 764532 - parenteral 1
BI 764532 - parenteral 1
BI 764532 - parenteral 2
BI 764532 - parenteral 2
Locations (12)
Winship Cancer Institute
Atlanta, Georgia, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Universitätsklinikum Köln (AöR)
Cologne, Germany
Technische Universität Dresden
Dresden, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, Germany
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
Hospital del Mar
Barcelona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain