AK112 y Quimioterapia para Cáncer Avanzado de las Vías Biliares

Fecha de inicio: 20 de octubre de 2024

Inclusion Criteria: * Be able and willing to provide written informed consent. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has a life expectancy of at least 3 months. * Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC). * Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC. * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Has adequate organ function. Exclusion Criteria: * Has other malignancies within 5 years prior to enrollment. * Is currently participating in a study of an investigational agent or using an investigational device. * Has known active central nervous system (CNS) metastases. * Has an active autoimmune disease that has required systemic treatment in the past 2 years. * Has an active infection requiring systemic therapy. * Has known active Hepatitis B or Hepatitis C. * History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Has received a live virus vaccine within 30 days of the planned first dose of study therapy. * Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.