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DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers


Active: Yes
Cancer Type: Neuroendocrine Tumor
Unknown Primary
NCT ID: NCT06132113
Trial Phases: Phase I Protocol IDs: 1438-0007 (primary)
NCI-2024-00432
2023-505870-13-00
U1111-1292-1400
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Boehringer Ingelheim Pharmaceuticals Inc
NCI Full Details: http://clinicaltrials.gov/show/NCT06132113

Summary

This study is open to adults aged 18 and older or above legal age who have a specific
type of advanced neuroendocrine cancer (NEC). Their tumours must be positive for a marker
called DLL3.

The purpose of this study is to test a medicine called BI 764532 in addition to
chemotherapy. The study has 2 parts. Part A of this study aims to find out the highest
dose of BI 764532 that people can tolerate in addition to chemotherapy. The purpose of
Part B is to find out how well people can tolerate BI 764532 in combination with
different chemotherapies. Researchers also want to find out whether BI 764532 in
combination with chemotherapy helps people with NEC.

Participants get different doses of BI 764532 as an infusion into a vein. In addition,
they get platinum-based chemotherapy as infusions into a vein. Participants can continue
treatment up to 3 years if they benefit from treatment and can tolerate it.

Participants visit their doctors regularly. During these visits, the doctors collect
information about participants' health and take note of any unwanted effects. Doctors
also regularly check the size of the tumour.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.