CTX-009 With Gemcitabine, Cisplatin, and Durvalumab as First-line Therapy in Patients With Unresectable or Metastatic Biliary Tract Cancers
Trial Parameters
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.
Eligibility Criteria
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 measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. 5. ECOG performance status ≤2 6. Patients must have adequate organ and marrow functio