[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659051":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":15,"studyPopulation":15,"armGroups":29,"interventions":35,"overallOfficials":15,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":15,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":15,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":15,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":96,"whyStopped":15,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Acepodia Biotech, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":15},[9,13,16,18,21],{"measure":10,"description":11,"timeFrame":12},"Part 1: To assess the safety and tolerability of ACE723 administered at multiple ascending doses","* Incidence of dose-limiting toxicities (DLTs) during the DLT evaluation period\n* Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)","Up to 12 months post-last dose",{"measure":14,"description":15,"timeFrame":12},"Part 1: To determine the maximum tolerated dose (MTD) of ACE723",null,{"measure":17,"description":15,"timeFrame":12},"Part 1: To determine the recommended ACE723 doses for further evaluation in the dose expansion phase",{"measure":19,"description":20,"timeFrame":12},"Part 2: To assess the safety and tolerability of ACE723 at the expansion doses","• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)",{"measure":22,"description":15,"timeFrame":12},"Part 2: To determine the Recommended Phase 2 Dose (RP2D) of ACE723 for further clinical evaluation",{"allocation":24,"interventionModel":25,"interventionModelDescription":15,"primaryPurpose":26,"observationalModel":15,"timePerspective":15,"maskingInfo":27},"NA","SINGLE_GROUP","TREATMENT",{"masking":28,"maskingDescription":15,"whoMasked":15},"NONE",[30],{"label":31,"type":32,"description":15,"interventionNames":33},"ACE723","EXPERIMENTAL",[34],"Drug: ACE723",[36],{"type":37,"name":31,"description":38,"armGroupLabels":39,"otherNames":15},"DRUG","Intravenous Administration",[31],[41],{"name":42,"role":43,"phone":44,"phoneExt":15,"email":45},"Acepodia Clinical Team","CONTACT","415 366 7822","clinical@acepodiabio.com",[47,58],{"facility":48,"status":15,"city":49,"state":15,"zip":15,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":15},"Nanjing Tianyinshan Hospital","Nanjing","China","CN",{"type":53,"coordinates":54},"Point",[55,56],118.77778,32.06167,{"lat":56,"lon":55},{"facility":59,"status":15,"city":60,"state":15,"zip":15,"country":50,"countryCode":51,"cosmosGeoPoint":61,"geoPoint":65,"contacts":15},"Zhongshan Hospital, Fudan University","Shanghai",{"type":53,"coordinates":62},[63,64],121.45806,31.22222,{"lat":64,"lon":63},{"type":67,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","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":79,"type":80},70,"ESTIMATED","INTERVENTIONAL",[83],"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).",[86,87,88],"Hepatocellular Carcinoma (HCC)","Hepatocellular Carcinoma Metastatic","Hepatocellular Carcinoma Non-Resectable",[31,90,91,92,93,94,95],"Antibody Drug Conjugate","ADC","Hepatocellular Carcinoma","HCC","Glypican-3","GPC-3","NOT_YET_RECRUITING","2026-10-05",{"date":99,"type":100},"2026-10-06","ACTUAL",{"date":102,"type":80},"2026-11",{"date":104,"type":80},"2030-05",{"name":5,"class":6},2]