[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gep-net\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gep-net":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,63,94,120],{"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":35,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100605639","phase-1-study-of-ryz401-in-subjects-with-solid-tumors-expressing-sstrs-100605639",false,"NCT07165132","Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.","Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.","Inclusion criteria:\n\n* At least 18 years old at the time of signing the main study informed consent form (ICF).\n* Histologically confirmed:\n\nDose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.\n\n* Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs\n* Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications:\n\n  * WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3)\n\n    * SSTR-positive disease, as assessed by SSTR-PET imaging\n    * Adequate renal, hematologic and hepatic function\n\nExclusion criteria:\n\n* Prior RPT, including Lu-177.\n* Prior solid organ or bone marrow transplantation.\n* Use of chronic systemic steroid therapy.\n* Significant cardiovascular disease\n* Resistant hypertension\n* Uncontrolled diabetes\n* Prior history of liver cirrhosis\n* HIV, hepatitis B infection or known active hepatitis C virus infection.\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":19,"type":20},104,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.",[26,27,28,29,30,31,32,33,34],"GEP-NET","Gastroenteropancreatic Neuroendocrine Tumor","Gastroenteropancreatic Neuroendocrine Tumor Disease","Neuroendocrine Tumors","Carcinoid","Carcinoid Tumor","Pancreatic NET","Solid Tumor","Somatostatin Receptor",[29,36,26,37,27,38,39,40,33,41,42,43,44,45,46,47,48,49],"SSTR+","Targeted Radiotherapy","Actinium","Ac 225","PRRT","Somatostatin Receptors","Radiopharmaceutical","BMS","Bristol Myers Squibb","Rayze","SSTR","RayzeBio","Well-differentiated NET","WD NETs","RECRUITING","2026-06-08",{"date":53,"type":54},"2026-06-09","ACTUAL",{"date":56,"type":54},"2025-12-03",{"date":58,"type":20},"2033-04",{"name":60,"class":61},"RayzeBio, Inc.","INDUSTRY",9,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100475949","phase-3-study-of-ryz101-compared-with-soc-in-pts-w-inoperable-sstr-well-differentiated-gep-net-that-has-progressed-following-177lu-ssa-therapy-100475949","NCT05477576","Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy","Phase 1b\u002F3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy","ACTION-1","Inclusion:\n\n* Histologically proven, Grade 1-2 well differentiated, inoperable, advanced GEP-NETs (Ki67 ≤20%) Eastern Cooperative Oncology Group (ECOG) status 0-2. Ki67% \\\u003C20% is not required for the ad hoc subcohort of the PK\u002FECG substudy.\n* Progressive, SSTR-PET positive (i.e., Krenning score 3 or 4) GEP-NET (GI or pancreas) following 2-4 cycles of treatment with 177Lu-labeled SSA. Must have achieved disease control for at least 6 months following Lu-177 SSA (archival tissue is not required for the ad hoc subcohort of the PK\u002FECG substudy). No time limit is defined between 177Lu-SSA treatment and randomization. There must be at least 1 SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and no RECIST v1.1 measurable metastatic lesions that are SSTR imaging-negative.\n* Adequate renal function, as evidenced by estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) (Levey et al. 2009)\n* Adequate hematologic function, defined by the following laboratory results:\n* Part 2: Hemoglobin concentration ≥5.0 mmol\u002FL (≥8.0 g\u002FdL); ANC ≥1000 cells\u002FµL (≥1000 cells\u002Fmm3); platelets ≥75 x 109\u002FL (75 x 103\u002Fmm3).\n* Total bilirubin ≤3 x upper limit normal (ULN)\n* Serum albumin ≥3.0 g\u002FdL unless prothrombin time is within the normal range\n\nExclusion:\n\n* Prior radioembolization\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) Class ≥II heart failure, left ventricular ejection fraction (LVEF) \\\u003C40% or QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 ms for males and \\>470 ms for females.\n* Resistant hypertension, defined as uncontrolled blood pressure (BP) \\>140\u002F90 mmHg while on optimal doses of at least 3 antihypertensive medications with 1 being a diuretic (Whelton et al. 2018)\n* Uncontrolled diabetes mellitus as defined by hemoglobin A1C (HgB A1C) ≥8%\n* PRRT other than Lu-177 SSA (not applicable for ad hoc subcohort of the PK\u002FECG substudy)\n* Any condition requiring systemic treatment with high-dose glucocorticoids within 14 days prior to first dose of study treatment and\u002For which cannot be stopped while on study. Inhaled or topical steroids are permitted.\n* Prior history of liver cirrhosis or liver transplantation",{"count":72,"type":20},338,[74],"PHASE3","This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE\u002FTOC), or 177Lu-high affinity \\[HA\\]-DOTATATE.",[26,27,28,29,30,31,32],[29,36,26,78,27,47,38,39,79,80,81,82,83,40,84],"targeted radiotherapy","Dotatate","Everolimus","sunitinib","octreotide","lanreotide","alpha emitter","2026-03-27",{"date":87,"type":54},"2026-03-30",{"date":89,"type":54},"2022-03-24",{"date":91,"type":20},"2030-12",{"name":60,"class":61},54,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":119},"100543484","influence-of-tumour-and-patients-related-factors-on-the-response-to-medical-treatments-in-well-differentiated-gep-nens-100543484","NCT06356467","Influence of Tumour and Patient's Related Factors on the Response to Medical Treatments in Well Differentiated GEP-NENs","FARINET","Inclusion Criteria:\n\n* Age \\>= 18\n* Well-differentiated, localized (but not suitable for surgical treatment) or advanced (locally or with distant metastasis) GEP-NENs\n* availability of data on site of primary tumor, stage of the, date of diagnosis\n* treated with one (or more) of the following therapies:\n\n  * Somatostatin analogs\n\n    * G1 or G2 (Ki67 \\\u003C10%) GEP-NENs\n    * Treated for at least 6 months\n    * first-line therapy (or as second-line after surgery in patients with residual disease or recurrence after surgical resection)\n  * Sunitinib\u002FEverolimus\n\n    * G1\u002FG2 GEP-NENs\n    * Treated for at least 6 months\n    * first- or second-line therapy\n  * Capecitabine-Temozolomide (CAP-TEM)\n\n    * G2 or G3 (Ki67 \\\u003C 55%) GEP-NENs\n    * first-, second-, or third-line therapy\n    * Treated for at least 6 months\n\nExclusion Criteria:\n\n* Age \\\u003C 18aa\n* Patients concomitantly treated with loco-regional treatments\n* Patients previously treated with radioligand therapy\n* Patients with need of CAP-TEM dose reduction of more than 33% for at least 3 administrations\n* NENs of unknown primitivity (including patients with biopsy on secondary lesion compatible with metastasis from GEP-NEN, but with occult primary neoplasm)\n* Patients with Mixed NENs (MiNENs)\n* Patients with poorly differentiated neuroendocrine carcinoma\n* Pregnancy and breastfeeding",{"count":102,"type":20},450,"OBSERVATIONAL","Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated.",[29,26],[107,108,26],"GEP-NEN","NEN","2026-01-14",{"date":111,"type":54},"2026-01-15",{"date":113,"type":54},"2023-11-21",{"date":115,"type":20},"2026-12-31",{"name":117,"class":118},"IRCCS San Raffaele","OTHER",1,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":119},"100547032","observational-study-on-gep-and-pulm-net-treated-at-fpg-100547032","NCT06402695","Observational Study on GEP-and Pulm-NET Treated at FPG","Observational Study on Clinical, Laboratory, Anatomopathological and Molecular Characteristics and Their Prognostic and Predictive Value in Patients With Neuroendocrine Tumors of the Gastroenteropancreatic Tract and Pulmonary Treated at Fondazione Policlinico Agostino Gemelli (FPG)-IRCCS","ETNA-FPG","Inclusion Criteria:\n\n* histological diagnosis of gastroenteropancreatic or pulmonary NET\n* age ≥ 18 years;\n* radiological evidence of resectable\u002Flocally advanced\u002Fmetastatic disease;\n* signing of informed consent;\n* at least one visit following the first oncological visit.\n\nExclusion Criteria:\n\n* absence of clinical data that allow adequate definition of survival (primary endpoint of the study);\n* absence of histological diagnosis;\n* failure to sign the informed consent.",{"count":129,"type":20},650,"Observational ambispective monocentric study on the clinical, laboratory, pathological and molecular characteristics of patients suffering from gastroenteropancreatic tract and pulmonary neuroendocrine tumors and their prognostic and predictive value.",[29,132,133],"Gep Net","Pulmonary Neuroendocrine Neoplasm","2024-05-03",{"date":136,"type":54},"2024-05-07",{"date":138,"type":54},"2023-09-15",{"date":140,"type":20},"2026-07",{"name":142,"class":118},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]