NCT04429087

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patients With Small Cell Lung Carcinoma and Other Neoplasms

Interventions

Type	Name	Description
DRUG	BI 764532 - parenteral 1	BI 764532 - parenteral 1
DRUG	BI 764532 - parenteral 2	BI 764532 - parenteral 2

Timeline

• Start date: 2020-07-29
• Primary completion: 2026-09-01
• Completion: 2027-02-15
• First posted: 2020-06-12
• Last updated: 2025-12-10

Locations

12 sites across 4 countries: United States, Germany, Japan, Spain

Regulatory

• FDA-regulated drug study