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A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer. Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. The doctors also regularly check the size of the tumour with imaging methods.
Official title: A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2026-02-24
Completion Date
2029-10-05
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
BI 3810944
BI 3810944
Locations (5)
University of Louisville
Louisville, Kentucky, United States
Tennessee Oncology, PLLC - Elliston Place Plaza DDU
Nashville, Tennessee, United States
Cliniques Universitaires Saint-Luc
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands