A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.

Inclusion criteria

• 18-75 years old, male or female.
• Histologically or cytologically confirmed diagnosis of advanced biliary tract cancer.
• Unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy).
• Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• ECOG performance status of 0-1.
• With a life expectancy of ≥3 months.
• Have adequate laboratory parameters and organ functions during the screening period.

Exclusion criteria

• Known history of hypersensitivity to any components of HRS-4642 or adebrelimab.
• Prior anti-tumor chemotherapy within 4 weeks before the study drug administration. Small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication.
• Patients with untreated or active central nervous system tumor metastasis.
• Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.