[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SmartNuclide Biopharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":119},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639865","early-phase-1-preliminary-trial-of-sna014-for-pancreatic-cancer-100639865",false,"NCT07597772","Preliminary Trial of SNA014 for Pancreatic Cancer","A Clinical Study on the Use of ⁶⁸Ga-labelled Claudin 18.2 as a Contrast Agent in Combination With PET\u002FCT for the Imaging of Pancreatic Cancer","Inclusion Criteria:\n\n1. Aged between 18 and 75 years (inclusive);\n2. Possessing legal capacity, voluntarily participating in this clinical trial, and having signed the informed consent form (ICF);\n3. Patients with a confirmed diagnosis of pancreatic cancer whose tumours are suitable for Claudin-18.2 testing;\n4. Results of gastroscopy, CT, MRI or PET-CT scans performed within the past month (if available);\n5. Pathology test results from within the past year;\n\nExclusion Criteria:\n\n1. Patients with other clearly diagnosed malignant tumours;\n2. Patients with uncontrolled severe infections, or those with other serious comorbidities;\n3. Patients with a life expectancy of ≤3 months;\n4. Pregnant or breastfeeding patients, and patients of childbearing potential who refuse to use appropriate contraception during the trial;\n5. Patients deemed unsuitable for participation in this study by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","68Ga labeled Claudin 18.2 contrast agent combined with PET\u002FCT for pancreatic cancer",[27],"Pancreatic Cancer",[29,30,31],"Pancreatic cancer","68Ga","Claudin 18.2","RECRUITING","2026-05-13",{"date":35,"type":36},"2026-05-19","ACTUAL",{"date":38,"type":36},"2025-10-01",{"date":40,"type":21},"2026-07-01",{"name":42,"class":43},"SmartNuclide Biopharma","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100639309","early-phase-1-a-preliminary-efficacy-of-sna028-in-patients-with-advanced-colorectal-cancer-positive-for-gpa33-100639309","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.",{"count":53,"type":21},20,[24],"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.",[57],"Colorectal Cancer",[59,60,61,62],"Colorectal cancer","GPA33","Radiopharmaceuticals","177Lu","NOT_YET_RECRUITING","2026-05-12",{"date":66,"type":36},"2026-05-15",{"date":68,"type":21},"2026-05-01",{"date":70,"type":21},"2027-12-01",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":44},"100638498","early-phase-1-a-iit-study-of-177lu-dota-sna040-100638498","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.",{"count":20,"type":21},[24],"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.",[83,84,85,86],"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)",[88,89],"Claudin18.2","177Lu-DOTA-SNA040",{"date":35,"type":36},{"date":92,"type":36},"2025-11-01",{"date":94,"type":21},"2027-06-01",{"name":42,"class":43},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":44},"100565792","early-phase-1-phase-iit-trial-of-sna014-100565792","NCT06646783","Phase IIT Trial of SNA014","Clinical Study of 68GA-labeled Claudin 18.2 Developer Combined with PET\u002FCT for Imaging of Gastric or Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer","Inclusion Criteria:\n\n* Age range of 18 to 75 years old (including boundary values);\n* Individuals with behavioral capacity who voluntarily participate in this clinical study and sign an informed consent form (ICF);\n* Diagnosed G\u002FGEJ adenocarcinoma and pancreatic cancer;\n* Gastroscopy\u002FCT\u002FMRI\u002FPET-CT examination results within the past month (if any);\n* Pathological test results and Claudin18.2 immunohistochemistry results within the past year (if available).\n\nExclusion Criteria:\n\n* Merge patients with other clearly diagnosed malignant tumors:\n* Uncontrolled severe infections or individuals with other serious illnesses;\n* Those with an expected survival period of less than or equal to three months;\n* Pregnant or lactating patients, as well as reproductive age patients who refuse to take appropriate contraceptive measures during this trial;\n* investigators determine that patients who are not suitable to participate in this study;",{"count":104,"type":21},28,[24],"68Ga labeled Claudin 18.2 contrast agent combined with PET\u002FCT for gastric or gastroesophageal junction",[108,109,110],"Adenocarcinoma of the Stomach","Adenocarcinoma of GE Junction","Pancreatic Cancer Stage","2024-10-15",{"date":113,"type":36},"2024-10-17",{"date":115,"type":21},"2024-10-20",{"date":117,"type":21},"2025-11-20",{"name":42,"class":43},""]