[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560970":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":64,"studyPopulation":57,"armGroups":65,"interventions":88,"overallOfficials":105,"centralContacts":110,"locations":57,"responsibleParty":116,"collaborators":57,"id":118,"slug":57,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":57,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":57,"enrollmentInfo":126,"targetDuration":57,"studyType":129,"phases":130,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":139,"whyStopped":57,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":57},{"fullName":5,"class":6},"Biotheus Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":57},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Objective response rate(ORR)","ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.","Up to approximately 2 years",{"measure":14,"description":15,"timeFrame":12},"Optimal dosing regimen of PM8002 in combination with PM1009","To determine the dosing regimen of PM8002 in combination with PM1009",{"measure":17,"description":18,"timeFrame":19},"Treatment related adverse events (TRAEs)","The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0","Up to 30 days after last treatment",[21,24,27,30,33,36,39,42,45,48,51,54],{"measure":22,"description":23,"timeFrame":12},"Objective response rate(ORR)(mRECIST)","ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on mRECIST",{"measure":25,"description":26,"timeFrame":12},"Disease control rate (DCR)","DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 and mRECIST",{"measure":28,"description":29,"timeFrame":12},"Duration of response (DOR)","DOR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first",{"measure":31,"description":32,"timeFrame":12},"Progression free survival (PFS)","PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first",{"measure":34,"description":35,"timeFrame":12},"Overall survival (OS)","OS is the time from the date of randomization or first dosing date to death due to any cause",{"measure":37,"description":38,"timeFrame":19},"Maximum observed concentration [Cmax]","To evaluate the Cmax of Combination regimen .",{"measure":40,"description":41,"timeFrame":19},"Time to Cmax [Tmax]","To evaluate the Tmax of Combination regimen .",{"measure":43,"description":44,"timeFrame":19},"Minimum observed concentration [Cmin]","To evaluate the Cmin of Combination regimen .",{"measure":46,"description":47,"timeFrame":19},"Area under the concentration-time curve [AUC0-last]","To evaluate the AUC0-last of Combination regimen .",{"measure":49,"description":50,"timeFrame":19},"AUC to the end of the dosing period(AUC0-tau)","To evaluate the AUC0-tau of Combination regimen .",{"measure":52,"description":53,"timeFrame":19},"Apparent terminal elimination half-life (t1\u002F2)","To evaluate the t1\u002F2 of Combination regimen .",{"measure":55,"description":56,"timeFrame":19},"Anti-drug antibody (ADA)","To evaluate the incidence of ADA to PM8002",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":63,"maskingDescription":57,"whoMasked":57},"NONE","The study is divided into two parts. The first part is a phase Ib, single-arm study, which is planned to enroll 3-28 subjects.\n\nThe second part is a phase II randomized, parallel-controlled, four-arm, open-label study, which is planned to enroll approximately 120 subjects.",[66,73,77,81],{"label":67,"type":68,"description":69,"interventionNames":70},"Cohort 1- combination treatment","EXPERIMENTAL","Combination regimen：PM8002 combined with PM1009. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).",[71,72],"Drug: PM8002","Drug: PM1009",{"label":74,"type":68,"description":75,"interventionNames":76},"Cohort 2- combination treatment","Combination regimen：PM8002 combined with PM1009(low dose). The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).",[71,72],{"label":78,"type":68,"description":79,"interventionNames":80},"Cohort 3- monotherapy","PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).",[71],{"label":82,"type":83,"description":84,"interventionNames":85},"Cohort 4","ACTIVE_COMPARATOR","Combination regimen：atezolizumab combined with bevacizumab. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).",[86,87],"Drug: atezolizumab","Drug: bevacizumab",[89,94,97,101],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":57},"DRUG","PM8002","PM8002 via IV infusion, Q3W",[67,74,78],{"type":90,"name":95,"description":92,"armGroupLabels":96,"otherNames":57},"PM1009",[67,74],{"type":90,"name":98,"description":99,"armGroupLabels":100,"otherNames":57},"atezolizumab","atezolizumab,1200mg, via IV infusion, Q3W",[82],{"type":90,"name":102,"description":103,"armGroupLabels":104,"otherNames":57},"bevacizumab","bevacizumab,15mg\u002Fkg, via IV infusion, Q3W",[82],[106],{"name":107,"affiliation":108,"role":109},"Jia Fan","Zhong Shan Hospital, Fudan University","PRINCIPAL_INVESTIGATOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":57,"email":115},"Xuelian Xing","CONTACT","+86 021 32120207","xing.xl@biotheus.com",{"type":117,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100560970",false,"NCT06584071","A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC","A Phase Ib\u002FII Clinical Trial to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of PM8002 Injection Combined With PM1009 Injection in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Voluntary participation in clinical studies;\n2. Male or female, aged ≥ 18 years;\n3. Pathologically or clinically confirmed (according to AASLD), unresectable locally advanced and\u002For metastatic HCC;\n4. Child-Pugh liver function score ≤7；\n5. No prior systemic therapy for locally advanced or metastatic and\u002For unresectable HCC；\n6. At least 1 measurable lesion ；\n7. Adequate organ function；\n8. ECOG score of 0 to 1；\n9. Life expectancy ≥ 12 weeks;\n\nExclusion Criteria:\n\n1. Pathologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma and other components；\n2. History of serious allergic diseases；\n3. The toxicity of previous anti-tumor therapy has not been alleviated；\n4. History of severe cardiovascular diseases within 6 months;\n5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;\n6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;\n7. History of alcohol abuse, psychotropic substance abuse or drug abuse;\n8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;\n9. Pregnant or lactating women;\n10. Other conditions considered unsuitable for this study by the investigator.","ALL","18 Years",{"count":127,"type":128},140,"ESTIMATED","INTERVENTIONAL",[131,132],"PHASE1","PHASE2","This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.",[135,136],"HCC","Liver Cancer",[138,135,95,91],"first line","NOT_YET_RECRUITING","2024-12-10",{"date":142,"type":143},"2024-12-16","ACTUAL",{"date":145,"type":128},"2024-12",{"date":147,"type":128},"2027-12",{"name":5,"class":6}]