[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638092":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":33,"responsibleParty":40,"collaborators":33,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":33,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":33,"enrollmentInfo":51,"targetDuration":33,"studyType":54,"phases":55,"briefSummary":58,"conditions":59,"keywords":33,"overallStatus":61,"whyStopped":33,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":33},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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).",[13,14],"Biological: SYS6006","Biological: Enlonstobart",{"label":16,"type":17,"description":18,"interventionNames":19},"Enlonstobart","ACTIVE_COMPARATOR","Phase II Investigational Treatment:Enlonstobart Intravenous infusion",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","SYS6006","Drug:SYS6006 Phase Ib dose level 1: SYS6006 Intramuscular injection; dose level 2: SYS6006 Intramuscular injection",[9],[27],"SYS6006 injection",{"type":22,"name":16,"description":29,"armGroupLabels":30,"otherNames":31},"Enlonstobart IV",[16,9],[32],"Enlonstobart injection",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":41,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100638092","phase-1-sys6006-in-combination-with-enlonstobart-injection-versus-enlonstobart-injection-in-participants-with-advanced-solid-tumors-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":52,"type":53},264,"ESTIMATED","INTERVENTIONAL",[56,57],"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.",[60],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-30",{"date":64,"type":65},"2026-06-03","ACTUAL",{"date":67,"type":53},"2026-05-29",{"date":69,"type":53},"2030-01-31",{"name":5,"class":6}]