[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06726161":3,"trial-entities:NCT06726161":234,"trial-summary:NCT06726161":238},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":40,"primary_purpose":41,"phases":42,"enrollment_info":45,"interventions":48,"primary_outcomes":59,"secondary_outcomes":77,"sex":78,"minimum_age":79,"maximum_age":17,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":127,"locations":130,"central_contacts":222,"overall_officials":228,"references":232,"see_also_links":233},"NCT06726161","RYZ801-101","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)","RECRUITING","2031-06","2026-04","2026-04-13","2025-09-05","RayzeBio, Inc.","INDUSTRY",true,"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)",null,[19],"Hepatocellular Carcinoma (HCC)",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"actinium","theranostic","alpha-emitter","RYZ811","RYZ801","225Ac","HCC","targeted radiotherapy","radiopharmaceutical","unresectable HCC","Rayze","RayzeBio","BMS","Bristol Myers Squibb","RPT","Imaging Agent","Hepatocellular Carcinoma","Diagnostic","GPC3","INTERVENTIONAL","TREATMENT",[43,44],"PHASE1","PHASE2",{"count":46,"type":47},590,"ESTIMATED",[49,55],{"type":50,"name":24,"description":51,"armGroupLabels":52},"DIAGNOSTIC_TEST","Ga-68",[53,54],"Dose Escalation, Dose Expansion (Dose Optimization\u002FRandomized Phase 2)","Standard of Care (SoC) (Randomized Phase 2)",{"type":56,"name":25,"description":57,"armGroupLabels":58},"DRUG","Ac-225",[53],[60,64,67,70,74],{"measure":61,"description":62,"timeFrame":63},"Therapeutic - RYZ801","To determine the RTA of RYZ801 in subjects with GPC3+ unresectable HCC (Dose Escalation only)","Rate of DLTs during the first 42 days of study treatment",{"measure":61,"description":65,"timeFrame":66},"To determine if treatment with RYZ801, compared to SoC therapy, improves ORR in subjects with GPC3+ unresectable HCC (Dose Expansion Stage 2 only) using ORR (rate of CR or PR), as determined by BICR according to RECIST v1.1","From enrollment for up to three months or study discontinuation, whichever occurs first.",{"measure":61,"description":68,"timeFrame":69},"To evaluate ORR of RYZ801 different dosing regimens (Dose Expansion Stage 1 only) and determine dosage optimized RP2D using ORR (rate of confirmed CR or PR) by RECIST v1.1 per investigator assessment","From enrollment to 3months after randomization or study discontinuation, whichever occurs first.",{"measure":71,"description":72,"timeFrame":73},"Diagnostic - RYZ811","To assess the safety and tolerability of RYZ811 in subjects with unresectable HCC. Safety and tolerability of RYZ811 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings.","Baseline, pre-injection and post-injection up to 6 days post injection.",{"measure":71,"description":75,"timeFrame":76},"To evaluate the biodistribution of RYZ811 in subjects with unresectable HCC. SUV (mean, maximum and peak) of organs and tumors; volume of RYZ811 avid uptake in tumor lesions; and tumor-to-normal organ tracer uptake ratios.","RYZ811 biodistribution to be assessed on the day of injection.",[],"ALL","18 Years",false,{"inclusion":82,"exclusion":103,"raw_text":126},[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],"Age of at least 18 years at the time of signing the informed consent form (ICF)","Histologically\u002Fcytologically confirmed diagnosis of HCC.","Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy","Child-Pugh A","Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)","Disease progression after 1 prior systemic therapy for unresectable HCC","Measurable disease per RECIST v1.1","Sufficient renal function","Adequate hematologic function","Adequate hepatic function","The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and\u002For stable on supportive therapy","If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.","Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding","For women of childbearing potential (WOCBP):","Negative serum pregnancy test within 48 hours prior to the first dose of RYZ811","Agreement to use barrier contraception and a second form of highly effective contraception","For sexually active males:","Must use a condom during intercourse","Male subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception","A condom is required to be used also by vasectomized men",[104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125],"Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma","Prior liver transplantation","Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801","Portal vein tumor thrombosis classified as Vp4","Documented hepatic encephalopathy within 6 months of enrollment","Clinically meaningful ascites within 6 months of enrollment","Prior EBRT to the liver within 12 weeks prior to receiving RYZ811","Prior liver radioembolization","Previously treated central nervous system (CNS) metastasis without recovery from acute side effects","Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis","Uncontrolled significant intercurrent illness including, but not limited to:","QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>470 ms","Hemoglobin A1c (Hgb A1c) ≥8%","Uncontrolled hypertension","Dose Expansion only: Prior treatment with lenvatinib is exclusionary","Significant cardiovascular disease or heart failure","History of clinically significant bleeding","Prior participation in any interventional clinical study","Current somatic or psychiatric disease\u002Fcondition that may interfere with the objectives and assessments of the study","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","Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study","Pregnancy or breastfeeding","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",[128,129],"ADULT","OLDER_ADULT",[131,140,147,153,160,167,174,181,188,195,201,208,215],{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":136,"geoPoint":137},"Research Facility","Birmingham","Alabama","35233","United States",{"lat":138,"lon":139},33.52066,-86.80249,{"facility":132,"status":8,"city":141,"state":142,"zip":143,"country":136,"geoPoint":144},"Phoenix","Arizona","85054",{"lat":145,"lon":146},33.44838,-112.07404,{"facility":132,"status":8,"city":148,"state":142,"zip":149,"country":136,"geoPoint":150},"Tucson","85719",{"lat":151,"lon":152},32.22174,-110.92648,{"facility":132,"status":8,"city":154,"state":155,"zip":156,"country":136,"geoPoint":157},"Orange","California","92868",{"lat":158,"lon":159},33.78779,-117.85311,{"facility":132,"status":8,"city":161,"state":162,"zip":163,"country":136,"geoPoint":164},"Jacksonville","Florida","32224",{"lat":165,"lon":166},30.33218,-81.65565,{"facility":132,"status":8,"city":168,"state":169,"zip":170,"country":136,"geoPoint":171},"Lexington","Kentucky","40536",{"lat":172,"lon":173},37.98869,-84.47772,{"facility":132,"status":8,"city":175,"state":176,"zip":177,"country":136,"geoPoint":178},"Baltimore","Maryland","21287",{"lat":179,"lon":180},39.29038,-76.61219,{"facility":132,"status":8,"city":182,"state":183,"zip":184,"country":136,"geoPoint":185},"Rochester","Minnesota","55905",{"lat":186,"lon":187},44.02163,-92.4699,{"facility":132,"status":8,"city":189,"state":190,"zip":191,"country":136,"geoPoint":192},"Omaha","Nebraska","68130",{"lat":193,"lon":194},41.25626,-95.94043,{"facility":132,"status":8,"city":196,"state":196,"zip":197,"country":136,"geoPoint":198},"New York","10065",{"lat":199,"lon":200},40.71427,-74.00597,{"facility":132,"status":8,"city":202,"state":203,"zip":204,"country":136,"geoPoint":205},"Houston","Texas","77030",{"lat":206,"lon":207},29.76328,-95.36327,{"facility":132,"status":8,"city":209,"state":210,"zip":211,"country":136,"geoPoint":212},"Charlottesville","Virginia","22908",{"lat":213,"lon":214},38.02931,-78.47668,{"facility":132,"status":8,"city":216,"state":217,"zip":218,"country":136,"geoPoint":219},"Seattle","Washington","98109",{"lat":220,"lon":221},47.60621,-122.33207,[223],{"name":224,"role":225,"phone":226,"email":227},"RayzeBio Clinical Trials","CONTACT","1-619-657-0057","clinicaltrials@rayzebio.com",[229],{"name":230,"affiliation":13,"role":231},"Freddy Escorcia, MD, PhD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":235,"biomarkers":236},[37],[237],"Glypican-3",{"nct_id":4,"found":15,"summary":239,"prompt_version":17},{"design":240,"status":241,"heading":242,"summary":243,"follow_up":244,"word_count":245,"commitments":246,"compensation":247,"drugs_mentioned":248},"This is a Phase 1\u002F2 randomized, controlled, open-label study involving up to 590 participants.","completed","Phase 1\u002F2 Study of RYZ811 and RYZ801 for Unresectable Liver Cancer","This study is testing two new treatments, RYZ811 (a diagnostic test) and RYZ801 (a therapeutic drug), for people with unresectable hepatocellular carcinoma (HCC), a type of liver cancer. You might be able to join if you are at least 18 years old, have HCC that has progressed after one prior treatment, and meet other specific health criteria. The researchers want to see how safe RYZ801 is and how well it works over the first 42 days, and then for up to three months after you start treatment or until you stop the study. The current recruitment status is unclear.","You will be followed for up to three months after starting treatment or until you leave the study, whichever comes first.",99,"Not specified in the trial record.","Not stated in the trial record.",[24,25]]