[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatocellular-carcinoma-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatocellular-carcinoma-metastatic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100659051","phase-1-phase-1-trial-of-ace723-a-dual-payload-antibody-drug-conjugate-in-patients-with-advanced-hcc-who-have-failed-or-progressed-on-standard-systemic-therapy-containing-icis-100659051",false,"NCT07861425","Phase 1 Trial of ACE723, A Dual-Payload Antibody Drug Conjugate, in Patients With Advanced HCC Who Have Failed or Progressed on Standard Systemic Therapy Containing ICIs","A Phase 1 Clinical Trial of ACE723, A Dual-Payload Antibody Drug Conjugate Targeting Glypican-3 (GPC-3), in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Who Have Failed or Progressed on Standard Immune Checkpoint Inhibitor-Containing Systemic Therapies","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years\n* HCC that is unresectable or metastatic\n* Pathologically confirmed HCC\n* Barcelona Clinic Liver Cancer (BCLC) stage B or C\n* Presence of at least 1 measurable lesion per RECIST 1.1\n* ECOG Performance Score of 0 or 1\n* Life expectancy of at least 3 months for the dose escalation portion and of at least 6 months for the dose expansion portion\n* Adequate bone marrow reserve\n* Adequate renal function\n* Adequate hepatic function\n* Left ventricular ejection fraction (LVEF) ≥50%\n* Ability to fully understand the investigational nature of this study\n* Agreement to contraception requirements\n\nExclusion Criteria:\n\n* Other types of hepatic malignancies, such as mixed cholangiocarcinoma\u002FHCC, sarcomatoid HCC, or fibrolamellar HCC,\n* History of another malignancy within the past 5 years\n* Ascites that requires non-pharmacologic intervention (e.g., paracentesis)\n* History of hepatic encephalopathy within 12 months\n* History of (non-infectious) ILD\u002Fpneumonitis\n* History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or known sensitivity or allergy to any components of ACE723.\n* History of bleeding events (including hematemesis or melena)\n* Active CNS metastases\n* Unresolved toxicities from prior anticancer therapy\n* Clinically significant active infection\n* Active syphilis infection and HIV infection\n* Pregnancy or breast-feeding women\n* Uncontrolled intercurrent illness\n* History of known substance abuse or illicit drug use\n* Poor compliance","ALL","18 Years","75 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","ACE723 is a dual-payload antibody drug conjugate targeting glypican-3 (GPC-3) that is under investigation for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC).",[27,28,29],"Hepatocellular Carcinoma (HCC)","Hepatocellular Carcinoma Metastatic","Hepatocellular Carcinoma Non-Resectable",[31,32,33,34,35,36,37],"ACE723","Antibody Drug Conjugate","ADC","Hepatocellular Carcinoma","HCC","Glypican-3","GPC-3","NOT_YET_RECRUITING","2026-10-05",{"date":41,"type":42},"2026-10-06","ACTUAL",{"date":44,"type":21},"2026-11",{"date":46,"type":21},"2030-05",{"name":48,"class":49},"Acepodia Biotech, Inc.","INDUSTRY",2]