[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590161":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":29,"studyPopulation":22,"armGroups":30,"interventions":40,"overallOfficials":22,"centralContacts":49,"locations":55,"responsibleParty":74,"collaborators":22,"id":76,"slug":22,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":22,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":22,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":22,"overallStatus":58,"whyStopped":22,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"HC Biopharma Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":22},[9],{"measure":10,"description":10,"timeFrame":11},"Incidence of Dose Limiting Toxicities(DLTs)","up to 24 months",[13,16,19],{"measure":14,"description":15,"timeFrame":11},"Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax)","Maximum serum concentration (Cmax)",{"measure":17,"description":18,"timeFrame":11},"Immunogenicity","Incidence of anti-drug antibodies (ADAs) to HC006",{"measure":20,"description":21,"timeFrame":11},"Objective Response Rate (ORR) per RECIST 1.1","The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE","HC006 is an IgG1 monoclonal antibody targeting CCR8, which can specifically clear CCR8-positive tumor infiltrating Treg cells without affecting CD8+ T cell function, thus enhancing the anti-tumor immune response. It has a synergistic effect on anti-tumor effects when combined with PD-1 inhibitors. Based on the existing evidence-based medicine, HC006 combined with PD-1 inhibitors is expected to provide additional treatment benefits in addition to PD-1 inhibitors for a variety of malignant solid tumors including colorectal cancer, head and neck squamous cell carcinoma, gastric cancer, non-small cell lung cancer, cervical cancer, breast cancer, esophageal cancer, pancreatic cancer, ovarian cancer, melanoma, urothelial cancer and renal cancer.",[31,37],{"label":32,"type":33,"description":22,"interventionNames":34},"HC006+ keytruda Dose Escalation","EXPERIMENTAL",[35,36],"Drug: HC006","Drug: KEYTRUDA ®( Pembrolizumab)",{"label":38,"type":33,"description":22,"interventionNames":39},"HC006 +keytruda Dose Expansion",[35,36],[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":22},"DRUG","HC006","Specified dose on specified days",[38,32],{"type":42,"name":47,"description":44,"armGroupLabels":48,"otherNames":22},"KEYTRUDA ®( Pembrolizumab)",[38,32],[50],{"name":51,"role":52,"phone":53,"phoneExt":22,"email":54},"Ke Yao, master","CONTACT","028-85142721","ke.yao@btyy.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200123","China","CN",{"type":65,"coordinates":66},"Point",[67,68],121.45806,31.22222,{"lat":68,"lon":67},[71],{"name":72,"role":52,"phone":22,"phoneExt":22,"email":73},"Ye Guo, MD","pattrickguo@gmail.com",{"type":75,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","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":86,"type":87},252,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93],"Advanced Cancer","2025-07-14",{"date":96,"type":97},"2025-07-17","ACTUAL",{"date":99,"type":97},"2025-07-04",{"date":101,"type":87},"2027-05-30",{"name":5,"class":6},1]