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Clinical Trials in China / NCT06413745
Active, not recruiting Phase 2

Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

NCT06413745 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 2
Started
2024-06-04
Last updated
2026-07-17

Condition(s) studied

HER2 Expression / Amplification in Patients With Biliary Tract Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 →

SHR-A1811: SHR-A1811

Study summary

This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.

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. Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation; 5. Subjects who failed or intolerance after systemic chemotherapies; 6. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion; 7. The main organ function is normal, in line with the program requirements ; 8. If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL; 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. Subjects with a history or evidence of brain metastasis or meningeal metastasis ; 3. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ; 4. Severe trauma or major surgery was performed within 4 weeks before the first administration; 5. To study the severe heart disease within 6 months before the first administration ; 6. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ; 7. Severe infection symptoms occurred within 2 weeks before the first administration; 8. Known hereditary or acquired bleeding and thrombotic tendency ; 9. Congenital or acquired immune defects; 10. The subjects had severe and uncontrollable concomitant diseases; 11. 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 (1)

FacilityCityRegionStatus
Zhongshan Hospital,Fudan University Shanghai Shanghai Municipality

More Jiangsu HengRui Medicine Co., Ltd. trials in China

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 NCT06413745 on ClinicalTrials.gov ↗ ← All trials in China