This study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial.
Aged 18-75 years old, including the boundary value, no gender restriction;
Meet the diagnostic criteria for advanced hepatocellular carcinoma established by histopathology and/or cytology, and have experienced failure of second-line therapy for advanced HCC (per 2024 CSCO Guidelines for Primary Liver Cancer). Patients must have progressed during or after at least two prior lines of standard systemic therapy (intolerant or refractory), with radiologically documented disease progression. Eligible stages are Barcelona Clinic Liver Cancer stage B or C, or stage IIb/IIIa/IIIb as defined in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (stage-IIb patients must be deemed unsuitable for surgery or TACE);
Have at least one measurable or evaluable lesion per RECIST 1.1;
GPC3 positivity confirmed by immunohistochemistry on a clinical pathology section;
Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.
Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.
Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.
History of leptomeningeal or central-nervous-system metastases.
Single group
SZ1003 injection
Drugonce every two weeks at a dose of SZ1003 injection per infusion.
Adverse events
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
Serious adverse events
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
Objective Response Rate
Every 8 weeks, objective response rate will be assessed according to RECIST 1.1..
Disease Control Rate
Every 8 weeks, disease control rate will be assessed according to RECIST 1.1..
Duration of Response
Every 8 weeks, duration of response will be assessed according to RECIST 1.1..
Progression-Free Survival
Every 8 weeks, progression-free survival will be assessed according to RECIST 1.1..
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This trial is not recruiting at the moment. You can still explore other options:
