Actively Recruiting
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-31
151
Participants Needed
2
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.
CONDITIONS
Official Title
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology
- Positive expression of CLDN18.2
- Previous failure or intolerance to systemic chemotherapy
- At least one measurable lesion according to RECIST v1.1
- Normal main organ function meeting study requirements
- Consent to use contraception
You will not qualify if you...
- Received anti-tumor treatments (chemotherapy, radiotherapy, immunotherapy, biotherapy, or clinical trial drugs) within 4 weeks before starting study treatment
- Other active cancers within the past 5 years or at the same time
- History or evidence of brain or meningeal metastasis
- Acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C
- Severe trauma or major surgery within 4 weeks before starting study treatment
- Severe heart disease within 6 months before starting study treatment
- Uncontrolled moderate or severe pleural effusion, ascites, or pericardial effusion requiring drainage
- Severe infection symptoms within 2 weeks before starting study treatment
- Known hereditary or acquired bleeding or clotting disorders
- Congenital or acquired immune deficiencies
- Severe and uncontrolled other medical conditions
- Cerebral infarction, pulmonary embolism, or deep vein thrombosis within 6 months before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
H
Haoyang Xin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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