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Clinical Trials in China / NCT07450976
Recruiting Phase 2

A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

NCT07450976 · tracked via the Priya Life Science China tracker
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Phase
Phase 2
Started
2026-03-25
Last updated
2026-03-31

Condition(s) studied

Biliary Tract Cancer

Investigational drug(s) / intervention(s)

SHR-A1904 for Injection

SHR-A1904 for Injection: SHR-A1904 for injection, different doses.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-75 years old (including both ends), male or female; 2. ECOG-PS score: 0 or 1; 3. Expected survival ≥ 12 weeks; 4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology; 5. CLDN18.2 positive expression; 6. Subjects who failed or intolerance after systemic chemotherapies; 7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion; 8. The main organ function is normal, in line with the program requirements; 9. Consent to contraception. Exclusion Criteria: 1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration; 2. Other active malignancies within 5 years or at the same time; 3. Subjects with a history or evidence of brain metastasis or meningeal metastasis; 4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C; 5. Severe trauma or major surgery was performed within 4 weeks before the first administration; 6. To study the severe heart disease within 6 months before the first administration; 7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage; 8. Severe infection symptoms occurred within 2 weeks before the first administration; 9. Known hereditary or acquired bleeding and thrombotic tendency; 10. Congenital or acquired immune defects; 11. The subjects had severe and uncontrollable concomitant diseases; 12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07450976 on ClinicalTrials.gov ↗ ← All trials in China