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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04752215
Other study ID # 1454-0001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 6, 2021
Est. completion date December 31, 2028

Study information

Verified date March 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is open to adults with advanced solid tumors whose previous cancer treatment was not successful. People can participate if their tumor has the B7-H6 marker or if they have colorectal cancer. The study tests 2 medicines called BI 765049 and ezabenlimab (BI 754091). Both medicines may help the immune system fight cancer. The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate. In this study, BI 765049 is given to people for the first time. Participants can stay in the study for up to 3 years, if they benefit from treatment and can tolerate it. During this time, they get BI 765049 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. The doctors check the health of the participants and note any health problems that could have been caused by BI 765049 or ezabenlimab. The doctors also regularly monitor the size of the tumor.


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Study Design


Intervention

Drug:
BI 765049
BI 765049
ezabenlimab
ezabenlimab

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Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) in any studied regimen defined as the highest dose with less than 25 percent (%) risk of the true dose limiting toxicity (DLT) rate being equal to or above 33 percent (%) during the MTD evaluation period Up to 3 weeks
Primary Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period Up to 3 weeks
Secondary Maximum measured concentration of BI 765049 (Cmax) Up to 36 months
Secondary Area under the concentration-time curve of BI 765049 over a uniform dosing interval t (AUCt) Up to 36 months
Secondary Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with measurable disease Up to 36 months

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