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Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With Ezabenlimab (BI 754091) in Solid Tumors
This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time. The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour. Participants get BI 1387446 injections every week at the beginning and then every 3 weeks. Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks. As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Vall d'Hebron
Barcelona, Spain
CIO Clara Campal
Madrid, Spain
Hospital Clínico de Valencia
Valencia, Spain
The Royal Marsden Hospital, Chelsea
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, United Kingdom
Start Date
August 3, 2020
Primary Completion Date
November 15, 2022
Completion Date
March 21, 2024
Last Updated
August 19, 2025
42
ACTUAL participants
BI 1387446 50 μg
DRUG
BI 754091
DRUG
BI 1387446 100 μg
DRUG
BI 1387446 200 μg
DRUG
BI 1387446 400 μg
DRUG
Lead Sponsor
Boehringer Ingelheim
NCT07159659
NCT07213804
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00026884