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)
Objective response rate (ORR) assessed by investigator. — Until progression, assessed up to approximately 1 year. Phase IIa.
Trial sites (2)
Facility
City
Region
Status
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
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.
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