[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"RayzeBio, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":191},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,52,81,124,161],{"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":27,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100644499","early-phase-1-imaging-study-of-a-caix-binder-in-metastatic-clear-cell-rcc-100644499",false,"NCT07671417","Imaging Study of a CAIX Binder in Metastatic Clear Cell RCC.","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Carbonic Anhydrase IX (CAIX) Binder in Subjects With Metastatic Clear Cell Renal Cell Cancer (RCC).","Inclusion Criteria:\n\n* At least 18 years old at the time of signing the informed consent form (ICF).\n* Biopsy proven metastatic clear cell renal cell carcinoma (RCC)\n\nExclusion Criteria:\n\n* Subjects taking below mentioned medications that cannot be stopped 5 half-lives prior to RYZ512 administration and cannot be restarted until all study-related imaging is completed: Anticonvulsants, Antipsychotics, Carbonic Anhydrase inhibitors, COX-2 Inhibitors, Sulfatase Inhibitors, Sulfonamides\n* Women of Childbearing Potential that are pregnant or breastfeeding.\n\nNote: Additional criteria may apply and will be assessed by the study site","ALL","18 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a novel Carbonic Anhydrase IX (CAIX) Binder in Subjects with Metastatic Clear Cell Renal Cell Cancer (RCC).",[26],"Metastatic Clear Cell Renal Cell Carcinoma",[28,29,30,31,32,33,34,35,36,37,38],"RCC","Metastatic RCC","Metastatic Clear Cell Renal Cancer","CAIX","CA9","RayzeBio","Rayze","BMS","Bristol Myers Squibb","RPT","Imaging Agent","NOT_YET_RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-26","ACTUAL",{"date":45,"type":20},"2026-06",{"date":47,"type":20},"2027-01",{"name":49,"class":50},"RayzeBio, Inc.","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":51},"100644477","early-phase-1-imaging-study-of-a-trop2-binder-in-metastatic-uc-hr-and-her2--breast-cancer-tnbc-and-nsclc-100644477","NCT07671092","Imaging Study of a TROP2 Binder in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC","A Phase 0 Imaging Study to Assess the Feasibility, Biodistribution, and Dosimetry of a Trophoblast Cell Surface Antigen 2 (TROP2) Binder in Metastatic Urothelial Cancer (UC), Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Breast Cancer, Triple-Negative Breast Cancer (TNBC), and Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Are at least 18 years old at the time of signing the informed consent form (ICF)\n* Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC\n\nExclusion Criteria:\n\n* TROP2-targeting antibody-drug conjugates (ADCs) such as sacituzumab govitecan or datopotamab deruxtecan, should be discontinued at least 90 days prior to administration of RYZ211 and RYZ212\n* For Women of Childbearing Potential: Are pregnant or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site",{"count":60,"type":20},40,[23],"This imaging study aims to assess the feasibility, biodistribution, and dosimetry of a TROP2 binder in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.",[64,65,66,67,68],"Metastatic Urothelial Carcinoma","Breast Cancer","TNBC - Triple-Negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","NSCLC",[70,71,65,72,73,74,75,33,34,35,36,37,38],"HR+","HER2-","Non Small Cell Lung Cancer","Triple Negative Breast Cancer","Trop2","TNBC",{"date":42,"type":43},{"date":45,"type":20},{"date":79,"type":20},"2027-10",{"name":49,"class":50},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":103,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100605639","phase-1-study-of-ryz401-in-subjects-with-solid-tumors-expressing-sstrs-100605639","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",{"count":89,"type":20},104,[91],"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.",[94,95,96,97,98,99,100,101,102],"GEP-NET","Gastroenteropancreatic Neuroendocrine Tumor","Gastroenteropancreatic Neuroendocrine Tumor Disease","Neuroendocrine Tumors","Carcinoid","Carcinoid Tumor","Pancreatic NET","Solid Tumor","Somatostatin Receptor",[97,104,94,105,95,106,107,108,101,109,110,35,36,34,111,33,112,113],"SSTR+","Targeted Radiotherapy","Actinium","Ac 225","PRRT","Somatostatin Receptors","Radiopharmaceutical","SSTR","Well-differentiated NET","WD NETs","RECRUITING","2026-06-08",{"date":117,"type":43},"2026-06-09",{"date":119,"type":43},"2025-12-03",{"date":121,"type":20},"2033-04",{"name":49,"class":50},9,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100571892","phase-1-study-of-the-theranostic-pair-ryz811-diagnostic-and-ryz801-therapeutic-to-identify-and-treat-subjects-with-gpc3-glypican-3-unresectable-hcc-100571892","NCT06726161","Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC","Phase 1\u002F2 Randomized, Controlled, Open-label Trial of Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ Unresectable Hepatocellular Carcinoma (HCC)","GPC3","Inclusion Criteria:\n\n* Age of at least 18 years at the time of signing the informed consent form (ICF)\n* Histologically\u002Fcytologically confirmed diagnosis of HCC.\n* Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy\n* Child-Pugh A\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)\n* Disease progression after 1 prior systemic therapy for unresectable HCC\n* Measurable disease per RECIST v1.1\n* Sufficient renal function\n* Adequate hematologic function\n* Adequate hepatic function\n* The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and\u002For stable on supportive therapy\n* If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.\n* Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding\n* For women of childbearing potential (WOCBP):\n\n  * Negative serum pregnancy test within 48 hours prior to the first dose of RYZ811\n  * Agreement to use barrier contraception and a second form of highly effective contraception\n* For sexually active males:\n\n  * Must use a condom during intercourse\n  * Male subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception\n  * A condom is required to be used also by vasectomized men\n\nExclusion Criteria:\n\n* Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma\n* Prior liver transplantation\n* Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801\n* Portal vein tumor thrombosis classified as Vp4\n* Documented hepatic encephalopathy within 6 months of enrollment\n* Clinically meaningful ascites within 6 months of enrollment\n* Prior EBRT to the liver within 12 weeks prior to receiving RYZ811\n* Prior liver radioembolization\n* Previously treated central nervous system (CNS) metastasis without recovery from acute side effects\n* Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis\n* Uncontrolled significant intercurrent illness including, but not limited to:\n\n  * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>470 ms\n  * Hemoglobin A1c (Hgb A1c) ≥8%\n  * Uncontrolled hypertension\n  * Dose Expansion only: Prior treatment with lenvatinib is exclusionary\n  * Significant cardiovascular disease or heart failure\n* History of clinically significant bleeding\n* Prior participation in any interventional clinical study\n* Current somatic or psychiatric disease\u002Fcondition that may interfere with the objectives and assessments of the study\n* Have a history of primary malignancy within the past 3 years other than (1) HCC, (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject's survival status for \\>3 years\n* Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study\n* Pregnancy or breastfeeding\n\nNote: Additional criteria may apply and will be assessed by the study site",{"count":133,"type":20},590,[91,135],"PHASE2","Phase 1\u002F2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)",[138],"Hepatocellular Carcinoma (HCC)",[140,141,142,143,144,145,146,147,148,149,34,33,35,36,37,38,150,151,130],"actinium","theranostic","alpha-emitter","RYZ811","RYZ801","225Ac","HCC","targeted radiotherapy","radiopharmaceutical","unresectable HCC","Hepatocellular Carcinoma","Diagnostic","2026-04-06",{"date":154,"type":43},"2026-04-13",{"date":156,"type":43},"2025-09-05",{"date":158,"type":20},"2031-06",{"name":49,"class":50},13,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},"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":170,"type":20},338,[172],"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.",[94,95,96,97,98,99,100],[97,104,94,147,95,33,106,107,176,177,178,179,180,108,181],"Dotatate","Everolimus","sunitinib","octreotide","lanreotide","alpha emitter","2026-03-27",{"date":184,"type":43},"2026-03-30",{"date":186,"type":43},"2022-03-24",{"date":188,"type":20},"2030-12",{"name":49,"class":50},54,""]