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RECRUITING
NCT04429087
PHASE1

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

View on ClinicalTrials.gov

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

DRUG

BI 764532 - parenteral 1

BI 764532 - parenteral 1

DRUG

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