[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radioiodine-refractory-differentiated-thyroid-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radioiodine-refractory-differentiated-thyroid-cancer":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100598211","sacituzumab-tirumotecan-combined-with-immunotherapy-in-advanced-thyroid-cancer-100598211",false,"NCT07068542","Sacituzumab Tirumotecan Combined With Immunotherapy in Advanced Thyroid Cancer","A Multicenter, Multi-Cohort, Phase II Study of Sacituzumab Tirumotecan With or Without Tislelizumab in Patients With Advanced Thyroid Cancer","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1\\. Age ≥ 18 years at the time of informed consent. 2. Histologically confirmed unresectable, locally advanced, or metastatic:\n\n* Anaplastic thyroid carcinoma (ATC), or\n* Poorly differentiated thyroid carcinoma (PDTC), or\n* Radioactive iodine-refractory differentiated thyroid carcinoma (RAIR-DTC), including papillary thyroid carcinoma or follicular thyroid carcinoma and variants.\n\n  3\\. For ATC or PDTC:\n* No BRAF V600E mutation, RET fusion, NTRK fusion, or ALK fusion;\n* Or harboring such alterations but have failed prior standard first-line targeted therapy.\n\n  4\\. For RAIR-DTC: Disease must be refractory to radioactive iodine (RAI), defined as at least one of the following:\n* No RAI uptake in measurable lesions;\n* Radiographic progression within 12 months after RAI therapy;\n* Cumulative RAI dose \\>600 mCi (or iodine-equivalent);\n* Fluorodeoxyglucose (FDG)-avid measurable disease;\n* Failure of prior multi-target tyrosine kinase inhibitor (TKI) therapy. 5. At least one measurable lesion per RECIST version 1.1. 6. ECOG performance status 0-2. 7. Life expectancy ≥ 12 weeks. 8. Adequate hematologic function:\n* Absolute neutrophil count ≥ 1.2 × 10⁹\u002FL\n* Platelet count ≥ 100 × 10⁹\u002FL\n* Hemoglobin ≥ 90 g\u002FL 9. Adequate hepatic function:\n* AST and ALT ≤ 2.5 × upper limit of normal (ULN)\n* ≤ 5 × ULN if liver metastases present\n* Total bilirubin ≤ 1.5 × ULN 10. Adequate renal function:\n* Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n\n  1. No active autoimmune disease requiring systemic therapy.\n  2. No concurrent active malignancy requiring treatment.\n  3. Willing and able to provide written informed consent.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Prior therapy targeting TROP2.\n2. Prior treatment with any topoisomerase I inhibitor antibody-drug conjugate.\n3. Prior immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40) or immune cell therapy.\n4. Another malignancy within 3 years prior to first dose, except adequately treated localized cancers (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix).\n5. Uncontrolled or symptomatic central nervous system metastases.\n\n   * Patients with treated and stable CNS disease for ≥4 weeks and off corticosteroids for ≥2 weeks may be eligible.\n6. Significant uncontrolled comorbidities including, but not limited to:\n\n   * Uncontrolled hypertension\n   * Severe diabetes mellitus\n   * Active infection\n7. History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, or current suspected ILD.\n8. Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (CTCAE v5.0), except alopecia or other clinically insignificant toxicities.\n9. Active autoimmune disease requiring systemic treatment within the past 2 years (excluding hormone replacement therapy such as levothyroxine or physiologic corticosteroids).\n10. Systemic corticosteroid use \\>10 mg\u002Fday prednisone equivalent within 10 days prior to first dose (except inhaled, topical, or physiologic replacement doses).\n11. Known HIV infection or AIDS. Active syphilis infection.\n12. History of allogeneic organ transplantation or hematopoietic stem cell transplantation.\n13. Known severe hypersensitivity to study drugs or components.\n14. Chemotherapy, radiotherapy, immunotherapy, biologic therapy, TKI, or systemic immune stimulation within protocol-defined washout period prior to first dose.\n15. Pregnant or breastfeeding women.\n16. Severe ocular disorders that may interfere with corneal healing (e.g., severe dry eye syndrome, severe meibomian gland disease).","ALL","18 Years",{"count":19,"type":20},94,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a multicenter, open-label, multi-cohort Phase II exploratory study designed to evaluate the efficacy and safety of sacituzumab tirumotecan with or without tislelizumab in patients with unresectable, locally advanced, or metastatic anaplastic thyroid carcinoma (ATC), poorly differentiated thyroid carcinoma (PDTC), or radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC).\n\nPatients with ATC will receive sacituzumab tirumotecan in combination with tislelizumab. Patients with PDTC and RAIR-DTC will receive sacituzumab tirumotecan monotherapy.\n\nThe primary objective in the ATC cohort is overall survival (OS). In the PDTC and RAIR-DTC cohorts, the primary objective is progression-free survival (PFS) assessed by investigators per RECIST v1.1.",[26,27,28],"Advanced Thyroid Carcinoma","Radioiodine-refractory Differentiated Thyroid Cancer","Poorly Differentiated Thyroid Carcinoma",[30,31,32,33,34,28,35],"radioiodine-refractory differentiated thyroid cancer","Sacituzumab tirumotecan","immunotherapy","TROP2","anaplastic thyroid carcinoma","Tislelizumab","RECRUITING","2026-05-27",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":40},"2025-07-01",{"date":44,"type":20},"2028-12-31",{"name":46,"class":47},"Zhejiang Provincial People's Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":48},"100585136","early-phase-1-study-of-177lu-lnc1004-injection-in-fap-positive-radioiodine-refractory-differentiated-thyroid-cancer-100585136","NCT06898437","Study of 177Lu-LNC1004 Injection in FAP-positive Radioiodine-refractory Differentiated Thyroid Cancer","Clinical Trial to Evaluate the Antitumor Efficacy and Safety of 177Lu-LNC1004 Injection in Patients With Fibroblast Activating Protein (FAP)-Positive Radioiodine-refractory Differentiated Thyroid Cancer (RAIR-DTC) Who Have Failed TKIs Treatment or Refuse Standard Treatment","Inclusion Criteria:\n\n1. Subject must have the ability to understand and sign an approved informed consent form (ICF).\n2. Aged 18 years or older, regardless of sex.\n3. Histologically or cytologically confirmed RAIR-DTC subject who has failed TKIs treatment or refuse standard therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n5. At least one measurable lesion as defined by Response Criteria in Solid Tumors (RECIST) version 1.1.\n6. Life expectancy of at least 6 months.\n7. FAP-positive lesion confirmed by FAPI PET\u002FCT scan.\n8. Adequate organ function as defined by：\n\n   * Bone marrow function: hemoglobin ≥ 100 g\u002FL, neutrophil count ≥ 1.5 × 109\u002FL, platelet count ≥ 100 × 109\u002FL;\n   * Liver function: albumin ≥ 3.0 g\u002FdL; total bilirubin ≤ 1.5 × ULN; ALT and AST \\\u003C 3 × ULN without liver metastasis or \\\u003C 5 × ULN with liver metastasis;\n   * Renal function: creatinine clearance ≥ 60 mL\u002Fmin.\n9. Clinically significant toxic reactions related to prior antitumor treatment that have recovered to Grade ≤ 1 (CTCAE V5.0).\n\nExclusion Criteria:\n\n1. Known central nervous system metastases, except for the following:\n\n   * Subject without clinical symptoms can be included in this trial after evaluation by the investigator.\n   * Brain metastases that have been previously treated and confirmed by image to be stable for at least 4 weeks.\n2. Secondary malignancy was detected within 5 years prior to first dosing, excluding cured localized carcinoma including cervical carcinoma in situ, basal cell skin cancer, and prostate cancer in situ, etc.\n3. Received antitumor treatment including chemotherapy, radiotherapy, immunotherapy, and traditional Chinese medicine, etc. within 4 weeks prior to first dosing.\n4. Subject who previously received targeted therapy, but discontinued treatment for less than 4 weeks or 10 half-lives prior to first dosing.\n5. Received systemic radionuclide therapy or radioembolization within 6 months before first dosing or any external beam radiotherapy within 2 weeks before the first dosing.\n6. Known allergy to 177Lu-LNC1004 Injection or similar drugs.\n7. Subject has not fully recovered from major surgery prior to first dosing or expects to have major surgery during the study period.\n8. Accompanied with severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n   * Subject who has undergone coronary angioplasty, coronary stent placement, coronary artery bypass grafting, or implantation of defibrillation devices due to arrhythmia within 6 months;\n   * There are serious heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block, etc.\n   * Clinically significant abnormal ECG during the screening period, including QTcF \\> 470 ms in male and QTcF \\> 480 ms in female.\n   * New York College of Cardiology (NYHA) grade ≥ 3.\n   * Aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular event (NCI CTCAE v5.0) within 6 months.\n9. Subject who has active and clinically significant bacterial, fungal, viral infection, or any other uncontrolled active infections such as active tuberculosis within 4 weeks prior to first dosing.\n10. Known human immunodeficiency virus (HIV) infection or positive HIV test, positive syphilis antibody test, or active hepatitis except for:\n\n    * Subject who is positive for hepatitis B surface antigen can be enrolled if HBV DNA level is less than 1×104 copies\u002FmL or 2000 IU\u002FmL, and can receive antiviral treatment according to clinical judgment during the trial.\n    * Subject who is positive for HCV antibodies can be enrolled if HCV RNA test is negative.\n11. Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n12. Subject who has pleural effusion or ascites that required treatment or is deemed uncontrollable by investigator.\n13. Subject who has mental illness or substance abuse, which may affect adherence to the trial.\n14. Subject who refuses to take effective contraceptive measures during sexual intercourse from ICF signing to 6 months after last investigational drug administration；\n15. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period or within 6 months after last investigational drug administration；\n16. Any other medical condition, metabolic abnormality, physical abnormality, laboratory abnormality, or other condition that the investigator deems inappropriate for study participation, or that would affect the interpretation of the study results, or place the subject at high risk, such as idiopathic pulmonary fibrosis or lung disease, urinary incontinence, etc.","85 Years",{"count":58,"type":20},20,[60],"EARLY_PHASE1","177Lu-LNC1004 Injection, a radiopharmaceutical targeting FAP, has demonstrated preliminary antitumor effect in advanced FAP-positive solid tumor patients. The primary purpose of this study is to evaluate the efficacy of 177Lu-LNC1004 Injection in patients with FAP-positive RAIR-DTC who have failed first-line TKIs treatment or refuse standard treatment. All subjects will receive 80 mCi (± 10%) 177Lu-LNC1004 Injection intravenously every 6 weeks for 2 cycles.",[63],"Radioiodine Refractory Differentiated Thyroid Cancer",[65,66,67],"Thyroid cancer","177Lu-LNC1004","FAP","2025-04-13",{"date":70,"type":40},"2025-04-15",{"date":72,"type":40},"2025-03-24",{"date":74,"type":20},"2027-03-23",{"name":76,"class":47},"Peking Union Medical College Hospital"]