Actively Recruiting
A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-31
151
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SHR-A1904 in a Phase 2 clinical trial for patients with advanced or metastatic biliary tract cancer who have previously received systemic treatment without success. The study aims to assess the drug's safety, effectiveness, how the body processes it, and the immune response it triggers. This trial focuses on patients with cancer expressing CLDN18.2 who have measurable tumors and a reasonable life expectancy. Participants will receive SHR-A1904 injections in either a low-dose or high-dose group. Treatment continues until the cancer worsens or side effects become unacceptable. The study is randomized without masking, meaning patients are assigned to one of the two dose groups openly. The treatment period may last up to about one year, with ongoing safety and immune monitoring. During the trial, participants will undergo regular assessments to measure tumor response, control of disease, time until response, and survival outcomes. Safety is monitored continuously by tracking adverse events and serious side effects. Immunogenicity tests will check for antibodies against SHR-A1904 for up to six months. Follow-up includes evaluation of overall survival for about two years, ensuring comprehensive monitoring of treatment effects and patient well-being throughout the study.
CONDITIONS
Brief 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 tissue analysis
- Positive expression of CLDN18.2 protein
- Failed or intolerant to prior systemic chemotherapies
- At least one measurable tumor lesion per RECIST v1.1 criteria
- Main organ functions within normal limits as required by the study
- Agreement to use contraception during the study period
You will not qualify if you...
- Received chemotherapy, radiotherapy, immunotherapy, biotherapy, or other anti-cancer treatments within 4 weeks before starting the study drug
- Presence of other active cancers within the past 5 years or at the same time
- History or evidence of brain or meningeal metastases
- Acute or chronic uncontrolled pancreatitis or severe liver dysfunction (Child-Pugh grade C)
- Major surgery or severe trauma within 4 weeks before starting the study drug
- Severe heart disease within 6 months before starting the study drug
- Uncontrolled moderate or severe fluid build-up in chest, abdomen, or around the heart requiring drainage
- Severe infection symptoms within 2 weeks before starting the study drug
- Known bleeding or clotting disorders
- Congenital or acquired immune system defects
- Severe and uncontrollable other medical conditions
- Recent cerebral infarction, pulmonary embolism, or deep vein thrombosis within 6 months before starting the study drug
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation, assessed up to approximately 1 year
Participants receive SHR-A1904 injections at low or high doses as assigned to their group.
Visits occur regularly during treatment for dosing and assessments
Duration - Up to approximately 2 years
Participants are monitored for overall survival and safety after treatment ends.
Periodic visits for safety and survival assessments
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
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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