NCT06548412

CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Metastatic Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Given by IV
DRUG	Cisplatin	Given by IV
DRUG	Durvalumab	Given by IV
DRUG	CTX-009	Given by IV

Timeline

• Start date: 2025-01-22
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2024-08-12
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study