[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"poorly-differentiated-thyroid-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:poorly-differentiated-thyroid-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100630276","phase-1-drug-repurposing-in-thyroid-carcinoma-a-feasibility-trial-100630276",false,"NCT07485569","Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial","Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial","REPOTHYROID-II","Inclusion Criteria:\n\n* Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.\n* Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).\n* Measurable disease per RECIST 1.1\n* ECOG performance status ≤ 2\n* Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inability to obtain a (new) biopsy for molecular profiling\n* Pregnancy or breastfeeding.\n* Other active malignancies requiring therapy.\n* Neutropenia (ANC \\\u003C 1.5 × 10⁹\u002FL).\n* Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).","ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.",[27,28,29,30],"Thyroid Cancer Stage IV","Anaplastic Thyroid Cancer","Differentiated Thyroid Cancer","Poorly Differentiated Thyroid Carcinoma",[32,33,34,35],"Drug repurposing","Thyroid cancer","Network pharmacology","Personalized therapy","NOT_YET_RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":21},"2026-06-01",{"date":44,"type":21},"2027-09-01",{"name":46,"class":47},"Radboud University Medical Center","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100598211","sacituzumab-tirumotecan-combined-with-immunotherapy-in-advanced-thyroid-cancer-100598211","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).",{"count":56,"type":21},94,[58],"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.",[61,62,30],"Advanced Thyroid Carcinoma","Radioiodine-refractory Differentiated Thyroid Cancer",[64,65,66,67,68,30,69],"radioiodine-refractory differentiated thyroid cancer","Sacituzumab tirumotecan","immunotherapy","TROP2","anaplastic thyroid carcinoma","Tislelizumab","RECRUITING","2026-05-27",{"date":42,"type":40},{"date":74,"type":40},"2025-07-01",{"date":76,"type":21},"2028-12-31",{"name":78,"class":47},"Zhejiang Provincial People's Hospital",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":79},"100565208","early-phase-1-177lulu-akir001-first-in-human-study-100565208","NCT06639191","[177Lu]Lu-AKIR001 First-in-human Study","A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours","AKIR001","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older\n2. Willing and able to provide written informed consent\n3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during\u002Fafter available standard of care treatment options as mentioned below:\n\n   * For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):\n\n     * For BRAFv600E mutated tumours: BRAF\u002FMEK inhibitors.\n     * For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy\u002F chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)\n     * For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)\n   * For HNSCC:\n\n     \\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \\\u003C1 (or if immunotherapy is contraindicated)\n   * For NSCLC\n\n     \\- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.\n   * For vulvar SCC:\n\n     \\- After treatment with first line platinum\u002Fpaclitaxel+\u002F-bevacizumab +\u002F- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel\n   * For cervical SCC:\n\n     * After treatment with first line systemic therapy with platinum\u002Fpaclitaxel+\u002F-pembrolizumab (the latter in case of PD-L1 positivity)\n4. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Life expectancy of at least three months as estimated by the investigator.\n7. Adequate organ and bone marrow function within eight days before the first \\[177Lu\\]Lu-AKIR001 infusion:\n\n   * Peripheral white blood cells (WBC) ≥3.0 x 109\u002FL\n   * Absolute neutrophil count (ANC) ≥ 2,000\u002Fmm3\n   * Platelet \\> 100 x 109\u002FL\n   * Hemoglobin \\> 100 g\u002FL.\n   * Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockcroft- Gault\n   * Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)\n   * Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)\n   * Left Ventricular Ejection Fraction \\>50% on echocardiography\n8. Contraceptives\n\n   * Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum pregnancy test before any \\[177Lu\\]Lu-AKIR001 infusion.\n   * Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases that are not previously treated and\u002For that require ongoing steroid-treatment\n2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.\n4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \\> 1 from previous anti-cancer treatments.\n5. Pregnancy or lactation\n6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical\u002F psychiatric disorders.\n7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.\n8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.",{"count":89,"type":21},15,[91],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \\[177Lu\\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:\n\n• What is the toxicity profile of the study drug \\[177Lu\\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \\[177Lu\\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.",[94,30,95,96,97,98],"Thyroid Gland Anaplastic Carcinoma","Cancer Head and Neck","Cervix Carcinoma","Vulvar Cancer, Stage IV","Non-small Cell Lung Cancer Stage IV",[100,101,102,103,104],"Radiopharmaceutical","first-in-human","CD44v6","Lutetium-177","177Lu-AKIR001","2026-01-28",{"date":107,"type":40},"2026-01-30",{"date":105,"type":40},{"date":110,"type":21},"2028-11-01",{"name":112,"class":47},"Karolinska University Hospital"]