About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- 177Lu-DOTA-SNA040