CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
M.D. Anderson Cancer Center
Summary
To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CTX-009 in combination with durvalumab, gemcitabine, and cisplatin in patients \<18 years of age, children are excluded from this study. 2. Ability to understand and the willingness to sign a written informed consent document. 3. Histologically or cytologically confirmed (outside pathology reports will be accepted) unresectable advanced, metastatic, or recurrent BTC at the time of enrollment that has not been previously treated in the metastatic setting. 4. Patients must have m…
Interventions
- DrugGemcitabine
Given by IV
- DrugCisplatin
Given by IV
- DrugDurvalumab
Given by IV
- DrugCTX-009
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas