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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

  • NCT04429087
  • PHASE1
  • INTERVENTIONAL

Last updated: 2024-04-10

Purpose of  Trial

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.


This study is for people with

Patients With Small Cell Lung Carcinoma and Other Neoplasms


Interventions being studied

BI 764532 - parenteral 1

BI 764532 - parenteral 2

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ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

3 Locations
Atlanta

Winship Cancer Institute


Georgia, 30322, United States
Saint Louis

Washington University School of Medicine


Missouri, 63110, United States
Pittsburgh

University of Pittsburgh Medical Center


Pennsylvania, 15232, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

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