[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560970":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":48,"centralContacts":53,"locations":36,"responsibleParty":59,"collaborators":36,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":36,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":36,"enrollmentInfo":70,"targetDuration":36,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":83,"whyStopped":36,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":36},{"fullName":5,"class":6},"Biotheus Inc.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13,14],"Drug: PM8002","Drug: PM1009",{"label":16,"type":10,"description":17,"interventionNames":18},"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).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"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).",[13],{"label":24,"type":25,"description":26,"interventionNames":27},"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).",[28,29],"Drug: atezolizumab","Drug: bevacizumab",[31,37,40,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","PM8002","PM8002 via IV infusion, Q3W",[9,16,20],null,{"type":32,"name":38,"description":34,"armGroupLabels":39,"otherNames":36},"PM1009",[9,16],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":36},"atezolizumab","atezolizumab,1200mg, via IV infusion, Q3W",[24],{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":36},"bevacizumab","bevacizumab,15mg\u002Fkg, via IV infusion, Q3W",[24],[49],{"name":50,"affiliation":51,"role":52},"Jia Fan","Zhong Shan Hospital, Fudan University","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":36,"email":58},"Xuelian Xing","CONTACT","+86 021 32120207","xing.xl@biotheus.com",{"type":60,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100560970","phase-1-a-study-to-evaluate-of-pm8002-combined-with-pm1009-in-patients-with-first-line-hcc-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":71,"type":72},140,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.",[79,80],"HCC","Liver Cancer",[82,79,38,33],"first line","NOT_YET_RECRUITING","2024-12-10",{"date":86,"type":87},"2024-12-16","ACTUAL",{"date":89,"type":72},"2024-12",{"date":91,"type":72},"2027-12",{"name":5,"class":6}]