Emavusertib (CA-4948) in Combination With Cisplatin, Gemcitabine, and Durvalumab in Patients With Untreated Advanced or Metastatic Biliary Tract Cancer
Trial Parameters
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Brief Summary
Based on preclinical data from the Lim lab (WUSM), the investigators hypothesize that IRAK4 inhibition cripples tumor-intrinsic survival signaling and effectively overcomes the desmoplastic and immune-suppressive tumor microenvironment (TME) to render chemo- and immunotherapies effective in GI malignancy. Therefore, this trial is designed to evaluate the combination of emavusertib (CA-4948) and standard chemoimmunotherapy in untreated advanced or metastatic biliary tract cancer (BTC).
Eligibility Criteria
Inclusion Criteria: * Advanced unresectable or metastatic histologically or cytologically confirmed adenocarcinoma of the biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. Patients whose tumor have mixed histology but predominantly (\>50%) adenocarcinoma are allowed. * Measurable defined by RECIST v1.1. * No prior systemic treatment for advanced unresectable or metastatic BTC with the following exceptions: * Neoadjuvant or adjuvant systemic therapy completed \> 6 months from planned C1D1. * Up to two prior cycles of gemcitabine/cisplatin/anti-PD1 with no evidence of disease progression is allowed * At least 18 years of age. * ECOG performance status 0, 1, or 2 * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1.5 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 x IULN or ≤ 3 x IULN in patients with documented Gilbert's syndrome * AST(SGOT)/ALT(SGPT) ≤ 2 x IULN, unl