[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590161":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"HC Biopharma Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"HC006+ keytruda Dose Escalation","EXPERIMENTAL",null,[13,14],"Drug: HC006","Drug: KEYTRUDA ®( Pembrolizumab)",{"label":16,"type":10,"description":11,"interventionNames":17},"HC006 +keytruda Dose Expansion",[13,14],[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","HC006","Specified dose on specified days",[16,9],{"type":20,"name":25,"description":22,"armGroupLabels":26,"otherNames":11},"KEYTRUDA ®( Pembrolizumab)",[16,9],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Ke Yao, master","CONTACT","028-85142721","ke.yao@btyy.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200123","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":11,"phoneExt":11,"email":51},"Ye Guo, MD","pattrickguo@gmail.com",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100590161","phase-1-study-of-hc006-in-combination-with-a-pd-1-inhibitor-in-patients-with-advanced-solid-tumors-100590161",false,"NCT06963814","Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors","A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial","Inclusion Criteria:\n\n1. Fully understand this trial and voluntarily sign the informed consent form;\n2. Advanced solid tumors diagnosed by histology or cytopathology;\n3. Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;\n4. At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);\n5. Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;\n6. The expected survival time is more than 3 months;\n7. Adequate organ and bone marrow function\n8. Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of investigational product and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).\n\nExclusion Criteria:\n\n1. Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;\n2. Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;\n3. Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;\n4. Conditions may significantly affect the autoimmune status;\n5. Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:\n6. Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;\n7. Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial;","ALL","18 Years","75 Years",{"count":65,"type":66},252,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.",[72],"Advanced Cancer","2025-07-14",{"date":75,"type":76},"2025-07-17","ACTUAL",{"date":78,"type":76},"2025-07-04",{"date":80,"type":66},"2027-05-30",{"name":5,"class":6},1]