[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endometrial-neoplasms-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endometrial-neoplasms-malignant":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100655721","phase-1-safety-and-diagnostic-performance-of-111in-tjd-31-spect-imaging-in-patients-with-solid-tumors-100655721",false,"NCT07815951","Safety and Diagnostic Performance of 111In-TJD-31 SPECT Imaging in Patients With Solid Tumors","A Single-Arm, Open-Label, Exploratory Clinical Study to Evaluate the Safety, Biodistribution, Dosimetry, and Preliminary Diagnostic Performance of a Novel SPECT Tracer 111In-TJD-31 in Patients With Solid Tumors","Inclusion Criteria:\n\n* For Patients with Solid Tumors:\n\n  1. Voluntary signed written informed consent before any study-specific procedures;\n  2. Clinically highly suspected or histologically (or cytologically) confirmed malignant solid tumors with measurable lesions (target lesions), including treatment-naïve and relapsed patients;\n  3. Age ≥18 and ≤75 years, male or female;\n  4. ECOG performance status 0 or 1;\n  5. Life expectancy ≥6 months;\n  6. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration.\n\nFor Healthy Volunteers:\n\n1. Chinese healthy volunteers, male or female;\n2. Age 18 to 55 years (inclusive);\n3. Body weight: females 45-80 kg (inclusive), males 50-80 kg (inclusive);\n4. Women of childbearing potential must have a negative pregnancy test, and all participants (including male participants) must agree to use effective contraception during the study period and for at least 3 months after study drug administration;\n5. Ability to communicate well with the investigator, understand and comply with all study requirements, and voluntarily sign informed consent before any study-related procedures.\n\nExclusion Criteria:\n\n* For Patients with Solid Tumors:\n\n  1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration;\n  2. Known or suspected allergy to the study drug or any of its components;\n  3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer;\n  4. Use of any radiotherapeutic agent within 90 days prior to study drug administration, or use of any radionuclide diagnostic agent within 3 days prior to study drug administration;\n  5. Significant hepatic or renal dysfunction: serum total bilirubin \\>1.5 × upper limit of normal (ULN), or AST and\u002For ALT \\>2.5 × ULN, or serum creatinine \\>1.5 × ULN;\n  6. Active infection at screening;\n  7. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging;\n  8. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.\n\nFor Healthy Volunteers:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within 3 months after study drug administration (except those who have been postmenopausal for at least 1 year or have undergone surgical sterilization such as bilateral tubal ligation without reversal, bilateral oophorectomy, or hysterectomy); or participants planning to donate sperm or eggs during the study period or within 3 months after study drug administration;\n2. Known or suspected allergy to the study drug or any of its components;\n3. Receipt of another investigational agent at enrollment, or within 5 half-lives or 30 days after the last dose of such agent, whichever is longer;\n4. Clinically significant abnormalities in hematology, blood biochemistry, or urinalysis at screening;\n5. History of any clinically significant disease (including but not limited to cardiac, hepatic, renal, digestive, biliary, endocrine, cardiovascular, neurological, psychiatric, respiratory, immunological, hematological, hematopoietic, or urinary system disease) within 4 weeks prior to screening, as judged by the investigator;\n6. Blood pressure \\>150\u002F100 mmHg or \\\u003C90\u002F50 mmHg at screening;\n7. Use of any prescription or over-the-counter medication (including herbal medicines, dietary supplements, and vitamins, except for routine continuous vitamin use) within 2 weeks prior to study drug administration, unless judged by the investigator as not affecting the study results;\n8. Blood donation or blood loss ≥500 mL within 12 weeks prior to study drug administration;\n9. History of any malignant tumor;\n10. Unable to lie flat and still for at least 30 minutes during SPECT imaging, or having claustrophobia or other conditions that preclude SPECT imaging;\n11. Any other condition that, in the investigator's opinion, makes the volunteer unsuitable for the study.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to evaluate the performance of a novel SPECT imaging agent, 111In-TJD-31, which targets placental alkaline phosphatase (ALPP). ALPP is a protein found on the surface of many malignant solid tumor cells but rarely present in healthy adult tissues. The purpose of this study is to assess the ability of 111In-TJD-31 to detect tumor lesions in patients with malignant solid tumors, as well as to evaluate its safety, biodistribution, pharmacokinetics, and radiation dosimetry.\n\nThe study will enroll 8 participants: 2 healthy volunteers and 6 patients with confirmed malignant solid tumors. Healthy volunteers will provide blood samples at multiple time points after a single intravenous injection of 111In-TJD-31 to help measure how the agent moves through the body. Patients with malignant solid tumors will receive a single intravenous injection of 111In-TJD-31 and undergo SPECT\u002FCT imaging at several time points post-injection. Participants will be followed for safety assessments through Day 7 after injection.\n\nThis is an open-label, exploratory study conducted at Zhongnan Hospital of Wuhan University, with support from Tuo Jiding (Jiaxing) Pharmaceutical Technology Co., Ltd.",[28,29,30,31,32,33,34],"Solid Tumors","Carcinoma","Ovarian Neoplasms","Endometrial Neoplasms Malignant","Testicular Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms",[36,37,38,39,40,41],"Placental Alkaline Phosphatase","SPECT Imaging","111In-TJD-31","Solid Tumor Diagnosis","radiation dosimetry","pharmacokinetics","NOT_YET_RECRUITING","2026-09-06",{"date":45,"type":46},"2026-09-11","ACTUAL",{"date":48,"type":22},"2026-09",{"date":50,"type":22},"2027-12-31",{"name":52,"class":53},"Yong He","OTHER"]