This clinical trial is a single-center, open-label, non-randomized first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of SNA028 (which is a two-step radioactivity pretargeting agents conducted by GPA33-CC and 177Lu-SmartD2) in patients with GPA33-positive colorectal cancer who have experienced disease progression/recurrence following prior standard 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;
Poor nutritional status and inability to tolerate the test subjects;
Individuals who have previously been allergic to SNA028 components or their analogues;
Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;
Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;
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Treatment groupsSee each treatment group below.
SmartNuclide Biopharma
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborator