[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640375":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":49,"overallOfficials":11,"centralContacts":54,"locations":11,"responsibleParty":60,"collaborators":11,"id":62,"slug":11,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":11,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":11},[9,13,16,19,21],{"measure":10,"description":11,"timeFrame":12},"Dose limiting toxicity (DLT)",null,"From Day 1 to Day 21",{"measure":14,"description":11,"timeFrame":15},"Frequency and severity of AE","From Day 1 to 30 days after last dose.",{"measure":17,"description":11,"timeFrame":18},"Maximal tolerable dose (MTD)","From Day 1 to 12 months.",{"measure":20,"description":11,"timeFrame":18},"Recommended phase 2 dose (RP2D)",{"measure":22,"description":11,"timeFrame":18},"ORR",[24,26,28,29,31,34],{"measure":25,"description":11,"timeFrame":18},"Cmax",{"measure":27,"description":11,"timeFrame":18},"AUCss,",{"measure":22,"description":11,"timeFrame":18},{"measure":30,"description":11,"timeFrame":18},"PFS",{"measure":32,"description":11,"timeFrame":33},"OS","From Day 1 to 18 months.",{"measure":35,"description":11,"timeFrame":33},"Positive rate for ADA",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"NON_RANDOMIZED","SINGLE_GROUP","This is the first-in-human phase I study of SYS6051 and this study consists of two part: a dose escalation and backfill part and a cohort expansion part.","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":11},"NONE",[44],{"label":45,"type":46,"description":11,"interventionNames":47},"SYS6051","EXPERIMENTAL",[48],"Drug: SYS6051",[50],{"type":51,"name":45,"description":52,"armGroupLabels":53,"otherNames":11},"DRUG","SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening\u002Fbaseline and prior to dosing at subsequent visits.",[45],[55],{"name":56,"role":57,"phone":58,"phoneExt":11,"email":59},"Clinical Trials Information Group","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100640375",false,"NCT07591285","A Study of SYS6051 in Subjects With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Fully understand the clinical study and voluntarily sign the written ICF;\n2. Age ≥ 18 years;\n3. Have at least one measurable lesion according to RECIST 1.1;\n4. ECOG performance status score of 0 to 1;\n5. Have adequate organ function;\n6. Expected survival of at least 3 months;\n7. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;\n8. Histologically or cytologically confirmed diagnosis of advanced solid tumors. -\n\nExclusion Criteria:\n\n1\\. Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease\u002Fpneumonitis requiring steroid hormone therapy or current interstitial lung disease\u002Fpneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.\n\n\\-","ALL","18 Years",{"count":71,"type":72},114,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.",[78],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-05-09",{"date":82,"type":83},"2026-05-15","ACTUAL",{"date":85,"type":72},"2026-05-12",{"date":87,"type":72},"2028-06-30",{"name":5,"class":6}]