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A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Sponsor: AIMEDBIO
Summary
This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time. Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated. Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.
Official title: A First-in-human Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-09-30
Completion Date
2030-05-13
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
BI 4060107
BI 4060107
Locations (6)
Texas Oncology - Irving
Irving, Texas, United States
Austin Health
Heidelberg, Victoria, Australia
Institut Gustave Roussy
Villejuif, France
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea