Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964233
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2019-05-24
Brief Title:
A Study in Patients With Different Types of Advanced Cancer Solid Tumors to Test Different Doses of BI 907828 Brigimadlin in Combination With BI 754091 Ezabenlimab and BI 754111 or BI 907828 Brigimadlin in Combination With BI 754091 Ezabenlimab
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Phase IaIb Open Label Dose-escalation Study of the Combination of BI 907828 Brigimadlin With BI 754091 Ezabenlimab and BI 754111 and the Combination of BI 907828 Brigimadlin With BI 754091Ezabenlimab Followed by Expansion Cohorts in Patients With Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 has 2 parts The first part of the study is done The first part was open to adults with different types of advanced cancer solid tumors The second part is open to people with specific types of soft tissue sarcoma advanced lung cancer and cancer in the stomach bladder or bile ducts
The participants get a combination of 2 medicines called brigimadlin also called BI 907828 and ezabenlimab also called BI 754091 Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer Ezabenlimab is an antibody that may help the immune system fight cancer immune checkpoint inhibitor When the study started some participants got a third medicine called BI 754111 in addition Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111
The purpose of the first part of the study was to find out the highest dose of brigimadlin that the participants could tolerate in combination with ezabenlimab This dose is used in the second part of the study
The purpose of the second part is to see whether the combination of brigimadlin with ezabenlimab is able to make tumors shrink
The participants are in the study as long as they benefit from treatment and can tolerate it
Ezabenlimab treatment is limited to 2 years During this time they get infusions of ezabenlimab and take tablets with brigimadlin every 3 weeks The doctors check how many participants have health problems during the study The doctors also monitor the size of the tumor
The participants get a combination of 2 medicines called brigimadlin also called BI 907828 and ezabenlimab also called BI 754091 Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer Ezabenlimab is an antibody that may help the immune system fight cancer immune checkpoint inhibitor When the study started some participants got a third medicine called BI 754111 in addition Treatment with BI 754111 was stopped because data from another study showed no additional effect of BI 754111
The purpose of the first part of the study was to find out the highest dose of brigimadlin that the participants could tolerate in combination with ezabenlimab This dose is used in the second part of the study
The purpose of the second part is to see whether the combination of brigimadlin with ezabenlimab is able to make tumors shrink
The participants are in the study as long as they benefit from treatment and can tolerate it
Ezabenlimab treatment is limited to 2 years During this time they get infusions of ezabenlimab and take tablets with brigimadlin every 3 weeks The doctors check how many participants have health problems during the study The doctors also 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001173-84 | EUDRACT_NUMBER | None | None |