A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer (NCT07450976) | Clinical Trial Compass
RecruitingPhase 2
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
China151 participantsStarted 2026-03-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Objective response rate (ORR) assessed by investigator.
Timeframe: Until progression, assessed up to approximately 1 year.
✕. 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;