RecruitingPhase 2NCT06413745
Phase II Clinical Study of SHR-A1811 in Patients With HER2 Expression / Amplification of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer
A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
65 participants
Start Date
Jun 4, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- Age 18-75 years old ( including both ends ), male or female ;
- ECOG-PS score : 0 or 1;
- Expected survival ≥ 12 weeks;
- Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
- Subjects who failed or intolerance after systemic chemotherapies;
- According to the RECIST v1.1 standard, the subjects had at least one measurable lesion；
- The main organ function is normal, in line with the program requirements ;
- If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be < 500 IU / mL；
- Consent to contraception.
Exclusion Criteria11
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
- Subjects with a history or evidence of brain metastasis or meningeal metastasis ;
- With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C ;
- Severe trauma or major surgery was performed within 4 weeks before the first administration;
- To study the severe heart disease within 6 months before the first administration ;
- Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage ;
- Severe infection symptoms occurred within 2 weeks before the first administration;
- Known hereditary or acquired bleeding and thrombotic tendency ;
- Congenital or acquired immune defects;
- The subjects had severe and uncontrollable concomitant diseases;
- Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study;
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Interventions
DRUGSHR-A1811
SHR-A1811
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06413745