To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
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.
Ability to understand and the willingness to sign a written informed consent document.
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.
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.
Previous treatment of the current malignancy. Patients who received prior perioperative treatment (adjuvant and neoadjuvant) are eligible.
History of active interstitial lung disease.
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on baseline imaging
Major surgical intervention within 28 days of Day 1 (Biliary stent placement, biliary stent exchange, and Endoscopic retrograde cholangiopancreatography (ERCPs) are not considered major surgical interventions)
M.D. Anderson Cancer Center
Lead sponsor
Compass Therapeutics, Inc
Collaborator