RecruitingPhase 2NCT07450976

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

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

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

151 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Cancer

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

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;
Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
CLDN18.2 positive expression;
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;
Consent to contraception.

Exclusion Criteria12

Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
Other active malignancies within 5 years or at the same time;
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.