[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastroenteropancreatic-neuroendocrine-tumor-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastroenteropancreatic-neuroendocrine-tumor-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"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]