Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04466891
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2020-07-06
Brief Title:
A Study of ZW25 Zanidatamab in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
A Phase 2b Open-label Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT04578444
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
HERIZON-BTC-01
Brief Summary:
This multicenter open-label single-arm trial will evaluate the anti-tumor activity of ZW25 zanidatamab monotherapy in subjects with human epidermal growth factor receptor 2 HER2-amplified inoperable and advanced or metastatic biliary tract cancer BTC including intra-hepatic cholangiocarcinoma ICC extra-hepatic cholangiocarcinoma ECC and gallbladder cancer GBC
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 |
|---|---|---|---|
| 2020-000459-11 | EUDRACT_NUMBER | None | None |
| 2023-508134-34-00 | OTHER | CTIS | None |