[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638498":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":74,"studyPopulation":67,"armGroups":75,"interventions":94,"overallOfficials":67,"centralContacts":100,"locations":106,"responsibleParty":125,"collaborators":67,"id":127,"slug":67,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":67,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":67,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":109,"whyStopped":67,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"SmartNuclide Biopharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":67},[9,13,17,19,21,23],{"measure":10,"description":11,"timeFrame":12},"Dose-limiting toxicity(DLT) of the single dose","Occurance of DLT in the first cycle of each group","4 to 6weeks",{"measure":14,"description":15,"timeFrame":16},"The safety and tolerance of 177Lu-DOTA-SNA040","The occurance and stage of AE and SAE according to CTCAE","4 to 6 weeks",{"measure":14,"description":18,"timeFrame":16},"The rates of abnormal laborotary tests after administration",{"measure":14,"description":20,"timeFrame":16},"The rates of abnormal vital signs after administration",{"measure":14,"description":22,"timeFrame":16},"The rates of abnormal physical examination after administration",{"measure":14,"description":24,"timeFrame":16},"The rates of abnormal 12-lead ECG after administration",[26,30,33,35,37,40,43,45,47,50,53,55,57,61,64],{"measure":27,"description":28,"timeFrame":29},"The biodistribution of SNA040","Absorbed dose in major organs throughout the body (red bone marrow, kidneys, liver, intestines, etc.)","1 week",{"measure":31,"description":32,"timeFrame":29},"The tumor uptake of SNA040","SUVmax and SUVmean of tumor",{"measure":31,"description":34,"timeFrame":29},"The retention time of tumor",{"measure":31,"description":36,"timeFrame":29},"The ID% of tumor",{"measure":38,"description":39,"timeFrame":29},"To evaluate the radiological characteristics 177Lu-DOTA-SNA040","Rradiation doses in whole blood, serum, urine measured using a gamma counter",{"measure":41,"description":42,"timeFrame":29},"The pharmacokinetic of the SNA040 protein","Peak plasma concentration (Cmax) of the SNA040",{"measure":41,"description":44,"timeFrame":29},"Area under the concentration-time curve (AUC) of the SNA040",{"measure":41,"description":46,"timeFrame":29},"Clearance (CL) of the SNA040",{"measure":48,"description":49,"timeFrame":29},"Assessment of the immunogenicity of SNA040","Occurance of positive immunogenicity test",{"measure":51,"description":52,"timeFrame":16},"Assessing tumour response according to RECIST1.1","The DCR of tumors",{"measure":51,"description":54,"timeFrame":16},"The ORR of tumors",{"measure":51,"description":56,"timeFrame":16},"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":60},"Explore the OS of subjects","Overall survival (OS) according to the RECIST1.1",{"measure":65,"description":66,"timeFrame":60},"the correlation between the clinical efficacy of SNA040 and Claudin18.2 expression","the correlation between overall response and Immunohistochemistry expression of Claudin18.2",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":71,"observationalModel":67,"timePerspective":67,"maskingInfo":72},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":73,"maskingDescription":67,"whoMasked":67},"NONE","Eligible subjects should first undergo 68Ga-NODAGA-SNA014 PET\u002FCT imaging. Patients with negative 68Ga-NODAGA-SNA014 tumor uptake will be discharged from the study after one week of follow-up for adverse events. Patients with positive 68Ga-NODAGA-SNA014 tumor uptake (SUVmax ≥10) will proceed to the subsequent 177Lu-DOTA-SNA040 dose escalation study (with at least a 2-day interval between 68Ga-NODAGA-SNA014 imaging and 177Lu-DOTA-SNA040 treatment). After completing the first cycle of dosing for DLT observation, subsequent 2-6 cycles of 177Lu-DOTA-SNA040 treatment may be administered. For dose group 1, the subsequent 2-6 cycles of 177Lu-DOTA-SNA040 dosing activity will be determined by the investigator, with the dose per cycle adjustable. For dose groups 2-4, the 177Lu-DOTA-SNA040 dosing activity will follow the fixed original dose (e.g., the first cycle dose for dose group 2 is 100 mCi, with subsequent 2-6 cycles fixed at 100 mCi).",[76,82,86,90],{"label":77,"type":78,"description":79,"interventionNames":80},"Group 1","EXPERIMENTAL","30\\~70mCi",[81],"Drug: 177Lu-DOTA-SNA040",{"label":83,"type":78,"description":84,"interventionNames":85},"Group 2","100mCi",[81],{"label":87,"type":78,"description":88,"interventionNames":89},"Group 3","150mCi",[81],{"label":91,"type":78,"description":92,"interventionNames":93},"Group 4","200mCi",[81],[95],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":67},"DRUG","177Lu-DOTA-SNA040","177Lu-DOTA-SNA040 administration",[77,83,87,91],[101],{"name":102,"role":103,"phone":104,"phoneExt":67,"email":105},"shaoli song, doctor","CONTACT","0512-67229125","mengru.wu@smartnucl.com",[107],{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200000","China","CN",{"type":116,"coordinates":117},"Point",[118,119],121.45806,31.22222,{"lat":119,"lon":118},[122],{"name":123,"role":103,"phone":67,"phoneExt":67,"email":124},"Shaoli Song, PhD","shaoli-song@163.com",{"type":126,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100638498",false,"NCT07595237","A IIT Study of 177Lu-DOTA-SNA040","A Clinical Study Evaluating the Safety, Tolerability, Biodistribution, Dose Determination, and Preliminary Efficacy of ¹⁷⁷Lu-DOTA-SNA040 in Patients With Claudin 18.2-positive Advanced Solid Tumors","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 advanced solid tumors confirmed by histopathology or cytology (such as gastric cancer or adenocarcinoma at the gastroesophageal junction, pancreatic cancer, and cholangiocarcinoma) and confirmed by the investigator, who fail to receive first-line treatment or have disease progression; According to RECIST 1.1 definition, there must be at least one measurable lesion;\n\n7\\. At least one lesion must be immunohistochemistry positive for Claudin18.2 (≥ 20% of tumor cells have Claudin18.2 immunohistochemistry membrane staining intensity ≥ 2+); Before the first administration of 177Lu-DOTA-SNA040 treatment, the toxicity caused by previous treatments must be restored to ≤ level 2 (CTCAE V5.0) or a stable state evaluated by the researcher (excluding hair loss and pigmentation); 177Lu DOTA-SNA040 has sufficient organ function one week before treatment, defined as follows:\n\n1. Bone marrow:\n\n   White blood cell count range from 3.0 to 10.0 × 10\\^9\u002FL Absolute neutrophil count range from 1.5 to 7.0 × 10\\^9\u002FL Platelets range from 75 to 300 × 10\\^9\u002FL Hemoglobin ≥ 90g\u002FL\n2. Liver:\n\n   Total bilirubin ≤ 2.5 x upper limit of normal (ULN) Serum albumin\\>3.0 g\u002FdL Alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN or liver metastasis patients ≤ 5 × ULN\n3. Kidney:\n\n   Serum\u002Fplasma creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL\u002Fmin (calculated using the Cockcroft Gault formula)\n4. Coagulation function The international standardized ratio of prothrombin is less than 1.5 × ULN Prothrombin time\\\u003C2 × ULN During the treatment with 177Lu-DOTA-SNA040, the best support\u002Fstandard of care agreed upon by the researcher is allowed; 11. 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. The nutritional status is extremely poor, with a BMI of less than 18.5 during screening, and the subjects cannot tolerate the test;\n2. Individuals who have previously been allergic to 177Lu DOTA-SNA040 or its analogues;\n3. Patients who have received therapeutic drugs and radiation therapy labeled with 177Lu and other radioactive isotopes 4 weeks before treatment with 177Lu DOTA-SNA040;\n4. 177Lu DOTA-SNA040 patients who received antibody conjugated drug (ADC) treatment 4 weeks before treatment;\n5. Those who have received other experimental anti-tumor drug treatments 4 weeks before 177Lu DOTA-SNA040 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. Patients with obvious gastric bleeding and\u002For untreated gastric ulcers;\n9. Diagnosed with other malignant tumors that may alter life expectancy or interfere with disease assessment;\n10. Pregnant or lactating women;\n11. The researcher believes that they are not suitable to participate in this clinical study.","ALL","18 Years","75 Years",{"count":137,"type":138},12,"ESTIMATED","INTERVENTIONAL",[141],"EARLY_PHASE1","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.",[144,145,146,147],"Advanced Solid Tumors (Such as Gastric Cancer)","Advanced Solid Tumors (Such as Adenocarcinoma at the Gastroesophageal Junction)","Advanced Solid Tumors (Such as Pancreatic Cancer)","Advanced Solid Tumors (Such as Cholangiocarcinoma)",[149,97],"Claudin18.2","2026-05-12",{"date":152,"type":153},"2026-05-19","ACTUAL",{"date":155,"type":153},"2025-11-01",{"date":157,"type":138},"2027-06-01",{"name":5,"class":6},1]