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NOT YET RECRUITING
NCT07827144
PHASE1

A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)

Sponsor: AIMEDBIO

View on ClinicalTrials.gov

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

BIOLOGICAL

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