Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 6:38 PM
Study NCT ID:
NCT06548412
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Sponsor:
M.D. Anderson Cancer Center
Organization:
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:
RECRUITING
Status Verified Date:
2025-07
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:
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 tolerability/safety 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 1.1
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 tolerability/safety 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 1.1
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-06735 | OTHER | NCI-CTRP Clinical Trials Registry | View |