Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03929666
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2019-02-22
Brief Title:
A Safety and Efficacy Study of ZW25 Zanidatamab Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers Including Gastroesophageal Adenocarcinoma Biliary Tract Cancer and Colorectal Cancer
Sponsor:
Jazz Pharmaceuticals
Organization:
Jazz Pharmaceuticals
Study Overview
Official Title:
Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastrointestinal GI Cancers Including Gastroesophageal Adenocarcinoma GEA Biliary Tract Cancer BTC and Colorectal Cancer CRC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is a multicenter global Phase 2 open-label 2-part first-line study to investigate the safety tolerability and anti-tumor activity of ZW25 zanidatamab plus standard first-line combination chemotherapy regimens for selected gastrointestinal GI cancers Eligible patients include those with unresectable locally advanced recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma GEA biliary tract cancer BTC or colorectal cancer CRC
Detailed Description:
Part 1 of the study will first evaluate the safety and tolerability of ZW25 plus standard first-line combination chemotherapy XELOX FP or mFOLFOX6 for GEA mFOLFOX6 with or without bevacizumab for CRC and CisGem for BTC and will confirm the recommended dosage RD of ZW25 when administered in combination with each of these multi-agent chemotherapy regimens Then Part 2 of the study will evaluate the anti-tumor activity of ZW25 plus combination chemotherapy in HER2-expressing GEA BTC and CRC
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