[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639309":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":45,"locations":51,"responsibleParty":65,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":44,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":44,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":44,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"SmartNuclide Biopharma","INDUSTRY",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose group 1","EXPERIMENTAL","GPA33-CC protein dosage 0.3mg\u002Fkg The interval is 7d and the mass dose of SmartD2 is 60nmol",[13],"Drug: GPA33-CC；177Lu-SmartD2",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose group 2","GPA33-CC protein dosage 1mg\u002Fkg. The interval is 7d and the mass dose of SmartD2 is 60nmol",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose group 3","GPA33-CC protein dosage 3mg\u002Fkg. The interval is 7d and the mass dose of SmartD2 is 60nmol",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose group 4","The interval is 3d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Dose group 5","The interval is 5d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Dose group 6","The mass dose of SmartD2 is 120nmol with optimal GPA33-CC protein dosage and interval.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Dose group 7","The mass dose of SmartD2 is 200nmol with optimal GPA33-CC protein dosage and interval.",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","GPA33-CC；177Lu-SmartD2","SNA028 is a two-step radioimmunotherapy, delivered as two separate products GPA33-CC and 177Lu-SmartD2, both will be administered as an IV infusion.",[9,15,19,23,27,31,35],null,[46],{"name":47,"role":48,"phone":49,"phoneExt":49,"email":50},"Dong Dai, Doctor","CONTACT","0512-23340123","1014481959@qq.com",[52],{"facility":53,"status":44,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":44},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300000","China","CN",{"type":60,"coordinates":61},"Point",[62,63],117.17667,39.14222,{"lat":63,"lon":62},{"type":66,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[68],{"name":53,"class":69},"OTHER","100639309","early-phase-1-a-preliminary-efficacy-of-sna028-in-patients-with-advanced-colorectal-cancer-positive-for-gpa33-100639309",false,"NCT07590856","A Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33","A Single-center, Open-label, Non-randomized Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SNA028 in Patients With Advanced Colorectal Cancer Positive for GPA33","Inclusion Criteria:\n\n1. Age range of 18 to 75 years old (including boundary values);\n2. Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);\n3. Individuals with ECOG scores ranging from 0 to 1 (see Appendix 1 for details);\n4. Life expectancy\\>6 months;\n5. Patients with colorectal cancer diagnosed by histopathology or cytology and experiencing imaging progression\u002Frecurrence after standard treatment;\n6. According to RECIST 1.1 definition, there must be at least one measurable lesion;\n7. Toxicity caused by previous treatment must be restored to ≤ level 2 (CTCAE v6.0) or to a stable state evaluated by the researcher (excluding hair loss and pigmentation);\n8. Having sufficient organ function, defined as follows:\n\n1\\) Bone marrow:\n\n* White blood cell count 3.0\\~10.0 × 10\\^9\u002FL\n* Absolute neutrophil count 1.5\\~7.0 × 10\\^9\u002FL\n* Platelets 75\\~300 × 10\\^9\u002FL\n* Hemoglobin ≥ 90g\u002FL 2) Liver:\n* Total bilirubin ≤ 2.5 x upper limit of normal (ULN)\n* Serum albumin\\>3.0 g\u002FdL\n* Alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN or liver metastasis patients ≤ 5 × ULN 3) Kidney:\n* Serum\u002Fplasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL\u002Fmin (calculated using the Cockcroft Gault formula) 4) Coagulation function\n* The international standardized ratio of prothrombin is less than 1.5 × ULN\n* Prothrombin time\\\u003C2 × ULN 9. Patients and\u002For partners with fertility must use adequate contraceptive measures during the study period and within 6 months after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. Poor nutritional status and inability to tolerate the test subjects;\n2. Individuals who have previously been allergic to SNA028 components or their analogues;\n3. Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before SNA028 treatment;\n4. Patients who have received other experimental anti-tumor drug treatments 4 weeks before SNA028 treatment;\n5. Patients who received anti-GPA33 antibody treatment 4 weeks before SNA028 treatment;\n6. Individuals known to have central nervous system metastases and\u002For malignant meningitis;\n7. Major comorbidities: including but not limited to New York Heart Association grade III or IV congestive heart failure, a history of congenital QT interval prolongation syndrome, active severe infections, or other major diseases that the researcher deems unsuitable for participation in the study;\n8. Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment;\n9. Pregnant or lactating women;\n10. The researcher believes that they are not suitable to participate in this clinical study.","ALL","18 Years","75 Years",{"count":81,"type":82},20,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","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\u002Frecurrence following prior standard therapy.",[88],"Colorectal Cancer",[90,91,92,93],"Colorectal cancer","GPA33","Radiopharmaceuticals","177Lu","NOT_YET_RECRUITING","2026-05-12",{"date":97,"type":98},"2026-05-15","ACTUAL",{"date":100,"type":82},"2026-05-01",{"date":102,"type":82},"2027-12-01",{"name":5,"class":6},1]