[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639309":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":72,"studyPopulation":68,"armGroups":73,"interventions":104,"overallOfficials":68,"centralContacts":110,"locations":116,"responsibleParty":130,"collaborators":132,"id":135,"slug":68,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":68,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":68,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":158,"whyStopped":68,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"SmartNuclide Biopharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":47},[9,13,15,17,19,21,25,27,29],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety and tolerability of SNA028 in patients with advanced colorectal cancer.","Occurrence of AE\u002FSAE after administration","3 weeks",{"measure":10,"description":14,"timeFrame":12},"Occurrence of abnormal Laboratory tests after administration",{"measure":10,"description":16,"timeFrame":12},"Occurrence of abnormal Vital signs after administration",{"measure":10,"description":18,"timeFrame":12},"Occurrence of abnormal Physical examination after administration",{"measure":10,"description":20,"timeFrame":12},"Occurrence of abnormal ECG after administration",{"measure":22,"description":23,"timeFrame":24},"To evaluate the pharmacokinetic of the GPA33-CC protein","Peak plasma concentration (Cmax) of the GPA33-CC","up to 1 week",{"measure":22,"description":26,"timeFrame":24},"half-life (t1\u002F2) of the GPA33-CC",{"measure":22,"description":28,"timeFrame":24},"Area under the concentration-time curve (AUC) of the GPA33-CC",{"measure":30,"description":31,"timeFrame":24},"To evaluate the radiological characteristics 177Lu-SmartD2.","Rradiation doses in whole blood and serum measured using a gamma counter radiological characteristics 177Lu-SmartD2 will be performed.",[33,37,39,41,43],{"measure":34,"description":35,"timeFrame":36},"To evaluate the biodistribution of SNA028","Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)","up to 2 weeks",{"measure":34,"description":38,"timeFrame":36},"Major organ and tumour standardised uptake (SUVmax and SUVmean)",{"measure":34,"description":40,"timeFrame":36},"The retention time of major organs and tumor.",{"measure":34,"description":42,"timeFrame":36},"The tumour-to-background ratio (TBR) of SUV",{"measure":44,"description":45,"timeFrame":46},"Assessment of the immunogenicity of GPA33-CC","Occurance of positive immunogenicity","4 weeks",[48,52,55,57,61],{"measure":49,"description":50,"timeFrame":51},"Assessing tumour response according to RECIST1.1","The ORR of tumor","every 6 weeks up to 2 years",{"measure":49,"description":53,"timeFrame":54},"The DCR of tumors.","Every 6 weeks up to 2 years",{"measure":49,"description":56,"timeFrame":51},"The DOR of tumors.",{"measure":58,"description":59,"timeFrame":60},"Explore the PFS of subjects","PFS according to the RECIST1.1","2 years",{"measure":62,"description":63,"timeFrame":64},"To evaluate the correlation between the clinical efficacy of SNA028 and GPA33 expression","the correlation between overall response and Immunohistochemistry expression of GPA33","up to 2 years",{"allocation":66,"interventionModel":67,"interventionModelDescription":68,"primaryPurpose":69,"observationalModel":68,"timePerspective":68,"maskingInfo":70},"NON_RANDOMIZED","SEQUENTIAL",null,"TREATMENT",{"masking":71,"maskingDescription":68,"whoMasked":68},"NONE","The trial is planned to explore three main topics: 1.the dose of GPA33-CC. 2. the intervation between administration of GPA33-CC Inervation and 177Lu-SmartD2. 3.the mass dose of SmartD2.",[74,80,84,88,92,96,100],{"label":75,"type":76,"description":77,"interventionNames":78},"Dose group 1","EXPERIMENTAL","GPA33-CC protein dosage 0.3mg\u002Fkg The interval is 7d and the mass dose of SmartD2 is 60nmol",[79],"Drug: GPA33-CC；177Lu-SmartD2",{"label":81,"type":76,"description":82,"interventionNames":83},"Dose group 2","GPA33-CC protein dosage 1mg\u002Fkg. The interval is 7d and the mass dose of SmartD2 is 60nmol",[79],{"label":85,"type":76,"description":86,"interventionNames":87},"Dose group 3","GPA33-CC protein dosage 3mg\u002Fkg. The interval is 7d and the mass dose of SmartD2 is 60nmol",[79],{"label":89,"type":76,"description":90,"interventionNames":91},"Dose group 4","The interval is 3d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage",[79],{"label":93,"type":76,"description":94,"interventionNames":95},"Dose group 5","The interval is 5d. The mass dose of SmartD2 is 60nmol with optimal GPA33-CC protein dosage",[79],{"label":97,"type":76,"description":98,"interventionNames":99},"Dose group 6","The mass dose of SmartD2 is 120nmol with optimal GPA33-CC protein dosage and interval.",[79],{"label":101,"type":76,"description":102,"interventionNames":103},"Dose group 7","The mass dose of SmartD2 is 200nmol with optimal GPA33-CC protein dosage and interval.",[79],[105],{"type":106,"name":107,"description":108,"armGroupLabels":109,"otherNames":68},"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.",[75,81,85,89,93,97,101],[111],{"name":112,"role":113,"phone":114,"phoneExt":114,"email":115},"Dong Dai, Doctor","CONTACT","0512-23340123","1014481959@qq.com",[117],{"facility":118,"status":68,"city":119,"state":120,"zip":121,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":129,"contacts":68},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300000","China","CN",{"type":125,"coordinates":126},"Point",[127,128],117.17667,39.14222,{"lat":128,"lon":127},{"type":131,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR",[133],{"name":118,"class":134},"OTHER","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":145,"type":146},20,"ESTIMATED","INTERVENTIONAL",[149],"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.",[152],"Colorectal Cancer",[154,155,156,157],"Colorectal cancer","GPA33","Radiopharmaceuticals","177Lu","NOT_YET_RECRUITING","2026-05-12",{"date":161,"type":162},"2026-05-15","ACTUAL",{"date":164,"type":146},"2026-05-01",{"date":166,"type":146},"2027-12-01",{"name":5,"class":6},1]