[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07164313":3,"trial-entities:NCT07164313":375,"trial-summary:NCT07164313":380},{"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":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":43,"secondary_outcomes":58,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":15,"eligibility_criteria":94,"std_ages":110,"locations":113,"central_contacts":363,"overall_officials":369,"references":373,"see_also_links":374},"NCT07164313","ZWI-ZW251-101","A Study of ZW251 in Participants With Advanced Solid Tumors","A First-In-Human, Phase 1, Open-Label, Multicenter Study of ZW251, a Novel Glypican-3 Targeting Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors, Including Hepatocellular Carcinoma","RECRUITING","2028-05","2026-05","2026-05-07","2025-10-21","Zymeworks BC Inc.","INDUSTRY",false,"The purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).","Part 1 (dose escalation) of the study will evaluate the safety and tolerability of ZW251 in HCC, squamous cell NSCLC, and GCT. Part 2 (dose optimization) of the study will further assess safety and potential anti-tumor activity of the ZW251 established recommended doses in HCC.",[19,20,21],"Hepatocellular Carcinoma","Squamous Cell Non-Small Cell Lung Cancer","Germ Cell Tumor",[23,24,25,26,27,28,29,21],"GPC3-expressing cancer","hepatocellular carcinoma","antibody drug conjugate","ADC","Lung Cancer","Non-Small Cell Lung Cancer","Squamous Cell Cancer","INTERVENTIONAL","TREATMENT",[33],"PHASE1",{"count":35,"type":36},100,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DRUG","ZW251","Administered intravenously",[40],[44,48,52,55],{"measure":45,"description":46,"timeFrame":47},"Incidence of dose-limiting toxicities (DLTs; Part 1)","Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251","Up to 3 weeks",{"measure":49,"description":50,"timeFrame":51},"Incidence of AEs (Parts 1 and 2)","Number of participants who experienced AEs, adverse events of special interest, or serious adverse events","Up to approximately 2 years",{"measure":53,"description":54,"timeFrame":51},"Incidence of clinical laboratory abnormalities (Parts 1 and 2)","Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0",{"measure":56,"description":57,"timeFrame":51},"Objective response rate (Part 2)","Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1",[59,62,64,67,70,73,76,79,82,85,88],{"measure":60,"description":61,"timeFrame":51},"Objective response rate (Part 1)","Number of participants who achieved a best overall response of either confirmed CR or PR during treatment according to RECIST v1.1",{"measure":63,"timeFrame":51},"Best overall response (Parts 1 and 2)",{"measure":65,"description":66,"timeFrame":51},"Disease control rate (Parts 1 and 2)","Number of participants who achieved a best response of CR, PR, or stable disease during treatment per RECIST v1.1",{"measure":68,"description":69,"timeFrame":51},"Duration of response (Parts 1 and 2)","The time from the first objective response (CR or PR) to the first documented progressive disease (PD) per RECIST v1.1 or death within 30 days of last dose of study treatment from any cause. Only participants who achieve a confirmed response will be included in the analysis",{"measure":71,"description":72,"timeFrame":51},"Progression-free survival (Part 2)","The time from the first dose of study treatment to the date of first documented PD per RECIST v1.1 or death from any cause",{"measure":74,"description":75,"timeFrame":51},"Area under the concentration-time curve (AUC0-504) of ZW251 (Parts 1 and 2)","Area under the concentration-time curve of ZW251 after first dose administration",{"measure":77,"description":78,"timeFrame":51},"Maximum concentration (Cmax) of ZW251 (Parts 1 and 2)","ZW251 maximum concentration after first dose administration",{"measure":80,"description":81,"timeFrame":51},"Area under the concentration-time curve of ZW251 at steady state (AUCtau,ss; Parts 1 and 2)","Area under the concentration-time curve of ZW251 at steady state after fourth dose administration",{"measure":83,"description":84,"timeFrame":51},"Maximum concentration of ZW251 at steady state (Сmax,ss; Parts 1 and 2)","ZW251 maximum concentration at steady state after fourth dose administration",{"measure":86,"description":87,"timeFrame":51},"Minimal concentration of ZW251 at steady state (Сmin,ss; Parts 1 and 2)","ZW251 minimal concentration at steady state after fourth dose administration",{"measure":89,"description":90,"timeFrame":51},"Incidence of anti-drug antibodies (ADAs; Parts 1 and 2)","Number of participants who develop ADAs","ALL","18 Years",null,{"inclusion":95,"exclusion":103,"raw_text":109},[96,97,98,99,100,101,102],"Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and\u002For metastatic disease. Noninvasive methods may be used to confirm diagnosis","Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and\u002For metastatic disease","Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and\u002For choriocarcinoma predominant component and locally advanced (unresectable) and\u002For metastatic disease","Measurable disease per RECIST v1.1","Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1","Liver function status of Child-Pugh Class A (for HCC only)","Adequate organ function",[104,105,106,107,108],"Known additional malignancy that is progressing or that has required active treatment within the last year","History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy","Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment","Known gastrointestinal bleeding within 3 months","Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease","Inclusion Criteria:\n\n* Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and\u002For metastatic disease. Noninvasive methods may be used to confirm diagnosis\n* Pathologically or cytologically confirmed diagnosis of squamous cell NSCLC with evidence of locally advanced (unresectable) and\u002For metastatic disease\n* Pathologically or cytologically confirmed diagnosis of GCT with evidence of yolk sac and\u002For choriocarcinoma predominant component and locally advanced (unresectable) and\u002For metastatic disease\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n* Liver function status of Child-Pugh Class A (for HCC only)\n* Adequate organ function\n\nExclusion Criteria:\n\n* Known additional malignancy that is progressing or that has required active treatment within the last year\n* History of hepatic encephalopathy within the past 6 months or requirement for medications to control encephalopathy\n* Participants with HCC experiencing main portal vein tumor invasion require sponsor approval for enrollment\n* Known gastrointestinal bleeding within 3 months\n* Acute or chronic uncontrolled renal disease, pancreatitis, or non-malignant liver disease",[111,112],"ADULT","OLDER_ADULT",[114,127,137,148,159,170,180,191,201,212,223,233,243,253,264,274,285,292,302,312,319,326,335,345,356],{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":119,"contacts":120,"geoPoint":124},"UCSF Comprehensive Cancer Center","San Francisco","California","94158","United States",[121],{"name":122,"role":123},"Katie Kelley, MD","PRINCIPAL_INVESTIGATOR",{"lat":125,"lon":126},37.77493,-122.41942,{"facility":128,"status":8,"city":129,"state":117,"zip":130,"country":119,"contacts":131,"geoPoint":134},"University of California Los Angeles - Cancer Care - Santa Monica (UCLA)","Santa Monica","90404",[132],{"name":133,"role":123},"Richard Finn, MD",{"lat":135,"lon":136},34.01949,-118.49138,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":119,"contacts":142,"geoPoint":145},"Norton Cancer Institute","Louisville","Kentucky","40202",[143],{"name":144,"role":123},"John Hamm, MD FACP, FASCO",{"lat":146,"lon":147},38.25424,-85.75941,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":119,"contacts":153,"geoPoint":156},"START Midwest","Grand Rapids","Michigan","49546",[154],{"name":155,"role":123},"Sreenivasa Chandana, MD, PhD",{"lat":157,"lon":158},42.96336,-85.66809,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":119,"contacts":164,"geoPoint":167},"Hackensack University Medical Center","Hackensack","New Jersey","07601",[165],{"name":166,"role":123},"Martin Gutierrez, MD",{"lat":168,"lon":169},40.88593,-74.04347,{"facility":171,"status":8,"city":172,"state":172,"zip":173,"country":119,"contacts":174,"geoPoint":177},"Memorial Sloan Kettering Cancer Center","New York","10065-6800",[175],{"name":176,"role":123},"Ghassan Abou-Alfa, MD, JD, MBA, PhD",{"lat":178,"lon":179},40.71427,-74.00597,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":119,"contacts":185,"geoPoint":188},"MD Anderson Cancer Center","Houston","Texas","77030",[186],{"name":187,"role":123},"Ecaterina Dumbrava, MD",{"lat":189,"lon":190},29.76328,-95.36327,{"facility":192,"status":8,"city":193,"state":183,"zip":194,"country":119,"contacts":195,"geoPoint":198},"START San Antonio","San Antonio","78229",[196],{"name":197,"role":123},"Muralidhar Beeram, MD, MBBS",{"lat":199,"lon":200},29.42412,-98.49363,{"facility":202,"status":8,"city":203,"zip":204,"country":205,"contacts":206,"geoPoint":209},"START - Dublin Mater Misericordiae University Hospital (MMUH)","Dublin","D07 R2WY","Ireland",[207],{"name":208,"role":123},"Austin Duffy, MD, DMed",{"lat":210,"lon":211},53.33306,-6.24889,{"facility":213,"status":8,"city":214,"zip":215,"country":216,"contacts":217,"geoPoint":220},"National Cancer Center East","Kashiwa","2778577","Japan",[218],{"name":219,"role":123},"Masafumi Ikeda, MD, PhD",{"lat":221,"lon":222},35.86224,139.97732,{"facility":224,"status":8,"city":225,"zip":226,"country":216,"contacts":227,"geoPoint":230},"Kyoto University Hospital","Kyoto","606-8507",[228],{"name":229,"role":123},"Takako Nakajima, MD",{"lat":231,"lon":232},35.02107,135.75385,{"facility":234,"status":8,"city":235,"zip":236,"country":216,"contacts":237,"geoPoint":240},"Kansai Medical University Hospital","Osaka","573-1191",[238],{"name":239,"role":123},"Toshio Shimizu, MD, PhD",{"lat":241,"lon":242},34.69379,135.50107,{"facility":244,"status":8,"city":245,"zip":246,"country":216,"contacts":247,"geoPoint":250},"National Cancer Center Hospital","Tokyo","104-0045",[248],{"name":249,"role":123},"Yuta Maruki, MD",{"lat":251,"lon":252},35.6895,139.69171,{"facility":254,"status":8,"city":255,"zip":256,"country":257,"contacts":258,"geoPoint":261},"START Lisboa a - Unidade de Ensaios ClÃnicos - Hospital de Santa Maria","Lisbon","1649-035","Portugal",[259],{"name":260,"role":123},"Andre Mansinho, MD, MSc",{"lat":262,"lon":263},38.72509,-9.1498,{"facility":265,"status":8,"city":266,"zip":267,"country":257,"contacts":268,"geoPoint":271},"Unidade Local de Saúde Gaia e Espinho","Vila Nova de Gaia","4434-502",[269],{"name":270,"role":123},"Andreia Capela, MD",{"lat":272,"lon":273},41.12401,-8.61241,{"facility":275,"status":8,"city":276,"zip":277,"country":278,"contacts":279,"geoPoint":282},"Hospital Universitario Vall d'Hebron","Barcelona","08035","Spain",[280],{"name":281,"role":123},"Jaume Capdevila Castillon, MD, PhD",{"lat":283,"lon":284},41.38879,2.15899,{"facility":286,"status":8,"city":276,"zip":287,"country":278,"contacts":288,"geoPoint":291},"START Barcelona","29010",[289],{"name":290,"role":123},"Tatiana Hernandez Guerrero, MD, PhD",{"lat":283,"lon":284},{"facility":293,"status":8,"city":294,"zip":295,"country":278,"contacts":296,"geoPoint":299},"START - Rioja Hospital Universitario San Pedro","Logroño","26006",[297],{"name":298,"role":123},"Maria Jose de Miguel Luken, MD",{"lat":300,"lon":301},42.46615,-2.45115,{"facility":303,"status":8,"city":304,"zip":305,"country":278,"contacts":306,"geoPoint":309},"START Madrid Hospital Universitario Fundacion Jimenez Diaz","Madrid","28040",[307],{"name":308,"role":123},"Manuel Pedregal Trujillo, MD",{"lat":310,"lon":311},40.4165,-3.70256,{"facility":313,"status":8,"city":304,"zip":314,"country":278,"contacts":315,"geoPoint":318},"START Madrid Hospital Universitario HM Sanchinarro - CIOCC","28050",[316],{"name":317,"role":123},"Emiliano Calvo, MD, PhD",{"lat":310,"lon":311},{"facility":320,"status":8,"city":304,"zip":321,"country":278,"contacts":322,"geoPoint":325},"NEXT Oncology Madrid","28223",[323],{"name":324,"role":123},"Valentina Boni, MD, PhD",{"lat":310,"lon":311},{"facility":327,"status":8,"city":328,"zip":287,"country":278,"contacts":329,"geoPoint":332},"Hospital Universitario Virgen de la Victoria","Málaga",[330],{"name":331,"role":123},"Javier Garcia Corbacho, MD",{"lat":333,"lon":334},36.72016,-4.42034,{"facility":336,"status":8,"city":337,"zip":338,"country":278,"contacts":339,"geoPoint":342},"Clinica Universidad de Navarra","Pamplona","31008",[340],{"name":341,"role":123},"Bruno Sangro, MD, PhD",{"lat":343,"lon":344},42.81687,-1.64323,{"facility":346,"status":8,"city":347,"zip":348,"country":349,"contacts":350,"geoPoint":353},"National Taiwan University Hospital","Taipei","100225","Taiwan",[351],{"name":352,"role":123},"Ann Lii Cheng, MD",{"lat":354,"lon":355},25.05306,121.52639,{"facility":357,"status":8,"city":347,"zip":358,"country":349,"contacts":359,"geoPoint":362},"Taipei Veterans General Hospital","112201",[360],{"name":361,"role":123},"Yi-Hsiang Huang, MD, PhD",{"lat":354,"lon":355},[364],{"name":365,"role":366,"phone":367,"email":368},"Zymeworks Clinical Trial Resource","CONTACT","(206) 237-1030","medinfo@zymeworks.com",[370],{"name":371,"affiliation":13,"role":372},"Maggie Weinstein, MD, PhD, MPH","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":376,"biomarkers":378},[21,19,377],"Lung Non-Small Cell Squamous Carcinoma",[379],"Glypican-3",{"nct_id":4,"found":381,"summary":382,"prompt_version":93},true,{"design":383,"status":384,"heading":385,"summary":386,"follow_up":387,"word_count":388,"commitments":389,"compensation":390,"drugs_mentioned":391},"This is an interventional study with an unclear phase, planning to enroll 100 participants. It will involve two parts: dose escalation and dose optimization.","completed","A Study of ZW251 for Advanced Solid Tumors","This study is testing a drug called ZW251 to see if it is safe and effective for people with advanced cancers, including hepatocellular carcinoma (HCC, a type of liver cancer), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors. ZW251 is an antibody-drug conjugate, which means it's designed to deliver a drug directly to cancer cells. The study will look at side effects (adverse events) and how well ZW251 works. You may be able to join if you are 18 or older and have one of these advanced cancers. The study is currently recruiting about 100 participants.","Participants will be followed for side effects and laboratory changes for up to approximately 2 years.",99,"Not specified in the trial record.","Not stated in the trial record.",[40]]