Actively Recruiting
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in Patients With Advanced Biliary Tract Tumors
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-02
49
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Confirmed diagnosis of advanced biliary tract cancer by tissue tests
- Unresectable or metastatic disease with progression or intolerance to at least one line of systemic therapy including gemcitabine-based chemotherapy
- At least one measurable tumor lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate laboratory and organ function at screening
You will not qualify if you...
- Known allergy to any components of HRS-4642 or adebrelimab
- Anti-tumor chemotherapy within 4 weeks before starting study treatment
- Use of small molecular targeted drugs with a half-life under 5 or 7 days before study
- Untreated or active central nervous system tumor metastasis
- Other factors that could affect study results or cause early study termination as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive HRS-4642 monotherapy or HRS-4642 combined with adebrelimab according to their assigned dose level.
Visits occur regularly during treatment to monitor response and adverse events
Trial Site Locations
Total: 1 location
1
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
Research Team
G
Guoming Shi, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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