Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752215
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2021-02-11
Brief Title:
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
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
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 Administrations in Patients With Malignant Solid Tumors Expressing B7-H6
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None