Study of HRS-4642 Alone or With Adebrelimab for Adults With Advanced Biliary Tract Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of HRS-4642 alone or combined with adebrelimab in treating patients with advanced biliary tract tumors. This phase 2 study focuses on patients with advanced disease that has progressed or who cannot tolerate previous treatments, including those who have undergone gemcitabine-based chemotherapy. The goal is to better understand how these treatments work in this patient group. Patients will receive either HRS-4642 alone at a fixed dose or a combination of HRS-4642 and adebrelimab. Treatment is given according to assigned dose levels in two experimental arms one for monotherapy and one for combination therapy. The study does not involve randomization or masking, and the treatments are administered under medical supervision. Participants will be monitored for up to two years to evaluate tumor response using RECIST v1.1 criteria and to track any adverse or serious adverse events. Other outcomes include disease control rate, progression-free survival, and overall survival. Screening includes lab tests and assessments to confirm adequate organ function, and participants will have regular evaluations during the study period to monitor treatment effects and safety.

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