Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653142
Status:
COMPLETED
Last Update Posted:
2022-05-10
First Post:
2020-11-27
Brief Title:
A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer Solid Tumors
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Phase I Study of BI 765063 Monotherapy and Its Combination Therapy With BI 754091 to Characterize Safety Pharmacokinetics and Pharmacodynamics in Japanese Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-05
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 Japanese adults with advanced cancer solid tumors This is a study in people for whom previous treatment was not successful and for whom no standard therapy exists The purpose of this study is to find the highest dose of BI 765063 that people can tolerate when taken alone or together with a medicine called BI 754091 BI 765063 and BI 754091 are antibodies that may help the immune system fight cancer checkpoint inhibitors
Participants get BI 765063 alone or together with BI 754091 as infusion every 3 weeks
Participants can stay in the study as long as they benefit from treatment and can tolerate it The doctors check the health of the participants and note any health problems that could have been caused by BI 765063 or BI 754091
Participants get BI 765063 alone or together with BI 754091 as infusion every 3 weeks
Participants can stay in the study as long as they benefit from treatment and can tolerate it The doctors check the health of the participants and note any health problems that could have been caused by BI 765063 or BI 754091
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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