This clinical trial is a single-center, open-label, non-randomized, first-in-human (FIH), dose-escalation study evaluating the safety, tolerability, and preliminary efficacy of 177Lu-DOTA-SNA040 in patients with advanced Claudin18.2-positive solid tumors (e.g., gastric cancer, gastroesophageal junction adenocarcinoma, pancreatic cancer, cholangiocarcinoma, etc.) who have disease progression following first-line therapy.
Age range of 18 to 75 years old (including boundary values);
Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);
Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details);
Life expectancy>6 months;
The nutritional status is extremely poor, with a BMI of less than 18.5 during screening, and the subjects cannot tolerate the test;
Individuals who have previously been allergic to 177Lu DOTA-SNA040 or its analogues;
Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before treatment with 177Lu DOTA-SNA040;
177Lu DOTA-SNA040 patients who received antibody conjugated drug (ADC) treatment 4 weeks before treatment;
Sequential
177Lu-DOTA-SNA040
Drug177Lu-DOTA-SNA040 administration
Dose-limiting toxicity(DLT) of the single dose
Occurance of DLT in the first cycle of each group
The safety and tolerance of 177Lu-DOTA-SNA040
The occurance and stage of AE and SAE according to CTCAE
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal laborotary tests after administration
The safety and tolerance of 177Lu-DOTA-SNA040
The rates of abnormal vital signs after administration
The biodistribution of SNA040
Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)
The tumor uptake of SNA040
SUVmax and SUVmean of tumor
The tumor uptake of SNA040
The retention time of tumor
The tumor uptake of SNA040
The ID% of tumor
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