Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05126472
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2021-11-08
Brief Title:
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study Evaluating the Safety and Tolerability of Locally Administered Anti-CD40 Agonist Antibody 2141-V11 in Subjects With Bladder Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety of the study drug 2141-V11 in people whose NMIBC did not respond to standard treatment and who will not have the standard surgical procedure to remove the bladder The researchers will test different doses of 2141-V11 to see which dose is safest in people The researchers will also do tests to see how the body absorbs distributes and gets rid of 2141-V11 This study is one of the first to test 2141-V11 in people and the first to test 2141-V11 delivered through a catheter into the bladder
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