Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548412
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
CTX-009 With Gemcitabine Cisplatin and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CTX-009 With Gemcitabine Cisplatin and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC
Detailed Description:
Primary Objectives
1 Assess tolerabilitysafety of this combination and determine the maximum tolerated dose MTD of CTX-009
2 Assess 6 month progression-free survival to the combination therapy according to RECIST 11
Secondary Objectives
1 Assess objective response rate ORR
2 Assess duration of response DOR
3 Assess overall survival OS
4 Assess progression free survival PFS
1 Assess tolerabilitysafety of this combination and determine the maximum tolerated dose MTD of CTX-009
2 Assess 6 month progression-free survival to the combination therapy according to RECIST 11
Secondary Objectives
1 Assess objective response rate ORR
2 Assess duration of response DOR
3 Assess overall survival OS
4 Assess progression free survival PFS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None