Clinical Trials Directory

Trials / Completed

CompletedNCT04752215

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface

A First-in-human Phase I, Non-randomized, Open-label, Multi-center Dose-escalation Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Parenteral Administration(s) in Patients With Malignant Solid Tumors Expressing B7-H6.

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBI 765049BI 765049
DRUGezabenlimabezabenlimab

Timeline

Start date
2021-05-18
Primary completion
2024-11-19
Completion
2024-12-17
First posted
2021-02-12
Last updated
2026-02-02

Locations

14 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT04752215. Inclusion in this directory is not an endorsement.