[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638092":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":11,"studyPopulation":11,"armGroups":58,"interventions":71,"overallOfficials":11,"centralContacts":84,"locations":11,"responsibleParty":90,"collaborators":11,"id":92,"slug":11,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":11,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":110,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":11},[9,13,16,18,21,23,26,29],{"measure":10,"description":11,"timeFrame":12},"Phase Ib: Incidence and frequency of dose-limiting toxicities (DLTs) during the study (applicable to the combination therapy dose-escalation phase)",null,"Within 21 days after the start of the treatment",{"measure":14,"description":11,"timeFrame":15},"Phase Ib: Incidence and frequency of treatment-emergent adverse events (TEAEs) .","Through study completion, an average of l year",{"measure":17,"description":11,"timeFrame":15},"Phase Ib:Incidence and frequency of serious adverse events (SAEs)",{"measure":19,"description":11,"timeFrame":20},"Phase Ib:Maximum tolerated dose (MTD)","Every 21 days while on treatment (estimated 6 months)",{"measure":22,"description":11,"timeFrame":20},"Phase Ib: Recommended Phase II dose (RP2D)",{"measure":24,"description":11,"timeFrame":25},"Phase II: ORR as assessed by the investigator according to RECIST v1.1","through study completion, an average of 1year.",{"measure":27,"description":11,"timeFrame":28},"Phase II: Incidence and frequency of TEAEs.","through study completion, an average of l year",{"measure":30,"description":11,"timeFrame":28},"Phase II:Incidence and frequency of SAEs.",[32,35,37,40,42,44,46,48,50],{"measure":33,"description":11,"timeFrame":34},"Disease control rate (DCR) per RECIST 1.1","Up to approximately 24 months after the first participant is enrolled",{"measure":36,"description":11,"timeFrame":34},"Duration of response (DoR) per RECIST 1.1",{"measure":38,"description":11,"timeFrame":39},"Progression free survival (PFS) per RECIST 1.1","Up to approximately 24months after the first participant is enrolled",{"measure":41,"description":11,"timeFrame":39},"Time to response(TTR)",{"measure":43,"description":11,"timeFrame":34},"Overall survival(OS)",{"measure":45,"description":11,"timeFrame":34},"Frequency and severity of adverse events (AEs) (NCI CTCAE 5.0)",{"measure":47,"description":11,"timeFrame":34},"PK parameters: The plasma concentration of enlonstobart",{"measure":49,"description":11,"timeFrame":34},"Correlation between PD-L1 expression level (measured as Tumor Proportion Score [TPS] by 22C3 IHC assay) and objective response rate (ORR, as assessed by RECIST 1.1 criteria)",{"measure":51,"description":11,"timeFrame":28},"To evaluate changes in cytokines such as interferon-alpha (IFNα) and the activation status of peripheral blood immune cells",{"allocation":53,"interventionModel":54,"interventionModelDescription":11,"primaryPurpose":55,"observationalModel":11,"timePerspective":11,"maskingInfo":56},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":57,"maskingDescription":11,"whoMasked":11},"NONE",[59,66],{"label":60,"type":61,"description":62,"interventionNames":63},"SYS6006 + Enlonstobart","EXPERIMENTAL","Phase Ib Dose Escalation Cohort Dose level 1 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.\n\nDose level 2 will consist of 3-6 patients who will receive SYS6006 and Enlonstobart.\n\n1. If 0\u002F3 participants experience a DLT, the next 3 participants can be enrolled to receive the same dose regimen, and escalation to the next dose group may proceed;\n2. If 1\u002F3 participants experience a DLT, an additional 3 participants will be enrolled to continue evaluation at the same dose regimen:\n\n   If a final total of 1\u002F6 participants experience a DLT, escalation to the next dose group may proceed; If ≥2 of the 6 evaluable participants experience a DLT, escalation will be stopped;\n3. If ≥2\u002F3 participants experience a DLT, escalation will be stopped.\n\nPhase II Investigational Treatment:The maximum safe dose of SYS6006 in combination Enlonstobart (as determined in the phase Ib cohort).",[64,65],"Biological: SYS6006","Biological: Enlonstobart",{"label":67,"type":68,"description":69,"interventionNames":70},"Enlonstobart","ACTIVE_COMPARATOR","Phase II Investigational Treatment:Enlonstobart Intravenous infusion",[65],[72,79],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"BIOLOGICAL","SYS6006","Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection",[60],[78],"SYS6006 injection",{"type":73,"name":67,"description":80,"armGroupLabels":81,"otherNames":82},"Enlonstobart IV",[67,60],[83],"Enlonstobart injection",[85],{"name":86,"role":87,"phone":88,"phoneExt":11,"email":89},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":91,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100638092",false,"NCT07622225","SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of SYS6006 in Combination With Enlonstobart Injection Versus Enlonstobart Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Able to understand and voluntarily sign the written informed consent form (ICF);\n* 2\\. Male or female subjects aged over 18 years old (inclusive).\n* 3\\. Patients with solid tumor who have unresectable locally advanced or metastatic disease;\n* 4\\. At least one measurable lesion, as defined by RECIST 1.1 criteria;\n* 5\\. ECOG performance status of 0-2;\n* 6\\. Expected survival ≥ 3 months;\n* 7\\. Adequate function of major organs and bone marrow;\n* 8\\. Women or man of childbearing potential must use highly effective contraception.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastases to meninges; with spinal cord compression; symptomatic and unstable brain metastasis;\n* 2\\. Patients with a history of autoimmune diseases;\n* 3\\. Presence of active infection (e.g., subjects are receiving anti-infection therapy);\n* 4\\. Severe or uncontrolled cardiovascular disorder requiring treatment;\n* 5\\. Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":101,"type":102},264,"ESTIMATED","INTERVENTIONAL",[105,106],"PHASE1","PHASE2","This study is a Phase Ib\u002FII clinical study. It includes two stages: Phase Ib and Phase II. In the Phase Ib stage, the primary objective is to evaluate the safety and tolerability of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors, and to provide a basis for dose selection in later clinical studies. The primary objective of the Phase II stage is to assess efficacy and safety of SYS6006 in combination with Enlonstobart Injection in participants with advanced solid tumors.",[109],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-30",{"date":113,"type":114},"2026-06-03","ACTUAL",{"date":116,"type":102},"2026-05-29",{"date":118,"type":102},"2030-01-31",{"name":5,"class":6}]