[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658993":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":65,"studyPopulation":65,"armGroups":73,"interventions":113,"overallOfficials":65,"centralContacts":124,"locations":65,"responsibleParty":130,"collaborators":65,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":65,"eligibilityCriteria":138,"healthyVolunteers":134,"sex":139,"minAge":140,"maxAge":65,"enrollmentInfo":141,"targetDuration":65,"studyType":144,"phases":145,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":153,"whyStopped":65,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":65},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":65},[9,13,15,18,21,25],{"measure":10,"description":11,"timeFrame":12},"The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study","Phase Ⅰ","Up to 90 days after last administration",{"measure":14,"description":11,"timeFrame":12},"The occurrence and frequency of Treatment-emergent adverse events (TEAEs)",{"measure":16,"description":11,"timeFrame":17},"The maximum tolerated dose (MTD) of SYS6088 (MTD, if any)","Up to approximately 18 weeks after the first participant is enrolled",{"measure":19,"description":11,"timeFrame":20},"The recommended Phase 2 dose (RP2D) of SYS6088","Up to approximately 36 weeks after the first participant is enrolled",{"measure":22,"description":23,"timeFrame":24},"Objective remission rate (ORR) assessed by the investigator according to RECIST v1.1","Phase Ⅱ","Up to approximately 3 years",{"measure":26,"description":23,"timeFrame":12},"The occurrence and frequency of TEAEs",[28,32,34,36,38,40,42,44,46,48,52,54,56,58,60,62,63],{"measure":29,"description":30,"timeFrame":31},"Plasma concentration and pharmacokinetic parameters after single and multiple doses ofSYS6088","Phase l,Cmax","Up to 30 days after last administration",{"measure":29,"description":33,"timeFrame":31},"Phase l, Tmax etc.",{"measure":35,"description":11,"timeFrame":31},"The incidence and titer of Anti-SYS6088 antibody (if applicable);",{"measure":37,"description":11,"timeFrame":31},"The titer of Anti-SYS6088 neutralizing antibody (if applicable);",{"measure":39,"description":11,"timeFrame":31},"Objective response rate (ORR) as assessed by the investigator per RECIST v1.1;",{"measure":41,"description":11,"timeFrame":24},"Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1",{"measure":43,"description":11,"timeFrame":24},"Disease control rate (DCR) as assessed by the investigator per RECIST v1.1",{"measure":45,"description":11,"timeFrame":24},"Duration of response (DoR) as assessed by the investigator per RECIST v1.1;",{"measure":47,"description":11,"timeFrame":24},"Time to response (TTR) as assessed by the investigator per RECIST v1.1",{"measure":49,"description":50,"timeFrame":51},"Overall survival (OS)","Duration from the date of initial treatment to the date of death due to any cause","Up to approximately 5 years",{"measure":53,"description":23,"timeFrame":24},"DCR assessed by the investigator according to RECIST v1.1;",{"measure":55,"description":23,"timeFrame":24},"PFS assessed by the investigator according to RECIST v1.1",{"measure":57,"description":23,"timeFrame":24},"DoR assessed by the investigator according to RECIST v1.1;",{"measure":59,"description":23,"timeFrame":24},"TTR assessed by the investigator according to RECIST v1.1",{"measure":61,"description":50,"timeFrame":51},"OS",{"measure":35,"description":23,"timeFrame":31},{"measure":37,"description":23,"timeFrame":64},"Up to 30 days after last",null,{"allocation":67,"interventionModel":68,"interventionModelDescription":69,"primaryPurpose":70,"observationalModel":65,"timePerspective":65,"maskingInfo":71},"NON_RANDOMIZED","SINGLE_GROUP","Dose escalation, expansion and cohort expansion","TREATMENT",{"masking":72,"maskingDescription":65,"whoMasked":65},"NONE",[74,79,83,86,91,95,98,102,105,109],{"label":75,"type":76,"description":11,"interventionNames":77},"SYS6088-Phase Ⅰ","EXPERIMENTAL",[78],"Drug: SYS6088",{"label":80,"type":76,"description":81,"interventionNames":82},"SYS6088 dose 1-cohort 1 of Phase Ⅱ","cohort 1 of Phase Ⅱ",[78],{"label":84,"type":76,"description":81,"interventionNames":85},"SYS6088 dose 2-cohort 1 of Phase Ⅱ",[78],{"label":87,"type":88,"description":81,"interventionNames":89},"Regorafenib","ACTIVE_COMPARATOR",[90],"Drug: Regorafenib",{"label":92,"type":76,"description":93,"interventionNames":94},"SYS6088 dose 1-cohort 2 of Phase Ⅱ","cohort 2 of Phase Ⅱ",[78],{"label":96,"type":76,"description":93,"interventionNames":97},"SYS6088 dose 2-cohort 2 of Phase Ⅱ",[78],{"label":99,"type":76,"description":100,"interventionNames":101},"SYS6088 dose 1","cohort 3 of Phase Ⅱ",[78],{"label":103,"type":76,"description":100,"interventionNames":104},"SYS6088 dose 2-cohort 3 of Phase Ⅱ",[78],{"label":106,"type":76,"description":107,"interventionNames":108},"SYS6088","cohort 4 of Phase Ⅱ",[78],{"label":110,"type":88,"description":107,"interventionNames":111},"Ivonescimab",[112],"Drug: Ivonescimab",[114,118,121],{"type":115,"name":106,"description":116,"armGroupLabels":117,"otherNames":65},"DRUG","SYS6088, administered per protocol.",[106,99,80,92,84,96,103,75],{"type":115,"name":87,"description":119,"armGroupLabels":120,"otherNames":65},"Regorafenib, administered per protocol.",[87],{"type":115,"name":110,"description":122,"armGroupLabels":123,"otherNames":65},"Ivonescimab, administered per protocol.",[110],[125],{"name":126,"role":127,"phone":128,"phoneExt":65,"email":129},"Clinical Trials Information Group officer","CONTACT","031169085587","ctr-contact@cspc.cn",{"type":131,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100658993","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-sys6088-in-patients-with-advancedmetastatic-solid-tumors-100658993",false,"NCT07857135","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced\u002FMetastatic Solid Tumors","A Phase Ⅰ\u002FⅡ Study of Dose Escalation, PK Expansion, and Cohort Expansion to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Malignant solid tumors confirmed by histology or cytology\n3. Patients who have failed standard anti-tumor treatment (disease progression or intolerance), have no available standard treatment or refuse standard treatment. (Phase 1)\n4. At least one measurable lesion that meets RECIST 1.1 criteria at baseline (the measurable lesion area has not received radiotherapy previously, or there is evidence that the lesion has clearly progressed after the end of radiotherapy) exists\n5. ECOG PS score ranges 0-1\n6. Expected survival period ≥ 3 months\n7. Adequate organ function.\n8. Participants must give informed consent to this study before the trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe allergies; Known hypersensitivity or intolerance to any component of the antibody drug and its excipients;\n2. Subjects with central nervous system metastasis or meningeal metastasis. Patients who have undergone targeted radiotherapy or surgical treatment and have no clinical symptoms and signs without drug symptomatic treatment can be enrolled;\n3. Patients with tumor invasion of important arteries leading to high risk of bleeding, obvious risk of perforation, or fistula formation; presence of diseases with impaired wound healing ability;\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n5. Adverse reactions of previous anti-tumor treatment (including radiotherapy) have not recovered to CTCAE 6.0 ≤ Grade 1;\n6. Occurrence of grade ≥3 immune-related adverse events (irAEs), or treatment discontinuation due to immune-related adverse events previously.\n7. Diagnosed with a second primary malignant tumor within 5 years before the first administration of the study drug; Except for effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, and\u002For effectively resected cervix cancer and\u002For breast cancer in situ;\n8. Received chemotherapy, biological therapy, targeted therapy and other anti-tumor treatments within 21 days before the first administration of the study drug;\n9. Received live or live-attenuated vaccines within 28 days prior to the first administration of study drug or planned to receive during the study;\n10. Use of immunosuppressive drugs within 14 days before the first administration of study drug;\n11. Use drugs with anticoagulant effects within 14 days before the first administration of study drug.\n12. Received palliative treatment for local lesions (including local radiotherapy or other local treatments) within 14 days before the first administration of study drug;\n13. Have undergone major surgery (excluding puncture biopsy) or severe traumatic injury 28 days before the first administration of study drug;\n14. Subjects with a history of severe cardiovascular disease；\n15. History or presence of interstitial pneumonia\u002Flung disease;\n16. History or presence of inflammatory bowel disease\n17. History of autoimmune diseases;\n18. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or organ transplantation;\n19. Infectious diseases requiring systemic anti-infective treatment;\n20. Active hepatitis B; Hepatitis C infection; Active syphilis infection, active tuberculosis;\n21. Lactating or pregnant women; women of childbearing potential have a positive blood pregnancy test within 7 days prior to trial enrollment; \\[A participant is of childbearing potential (judged by the investigator) when he\u002Fshe is biologically capable of fathering a child and is sexually active. Female participants who are not of childbearing potential (i.e., meet at least 1 of the following criteria): have had a hysterectomy or bilateral oophorectomy, or have medically confirmed ovarian failure, or are medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months without a pathological or physiological cause).\\]\n22. Any male and female participants of childbearing potential who refuse to use effective contraceptive methods throughout the trial and within half a year after the last administration;\n23. Other conditions that the investigator believes will affect the safety or compliance of the study drug treatment, including but not limited to: mental illness, any severe or uncontrolled disease, etc","ALL","18 Years",{"count":142,"type":143},140,"ESTIMATED","INTERVENTIONAL",[146,147],"PHASE1","PHASE2","This study is a multi-center, open-label, dose-escalation, dose-expansion, and cohort-expansion first-in-human Phase 1\u002F2 study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6088 in patients with advanced\u002Fmetastatic solid tumors.",[150],"Advanced\u002FMetastatic Solid Tumors",[152],"SYS6088, PD-1, CTLA-4, VEGF, Trispecific antibody, tumor","NOT_YET_RECRUITING","2026-09-28",{"date":156,"type":157},"2026-10-05","ACTUAL",{"date":159,"type":143},"2026-10-03",{"date":161,"type":143},"2029-08-03",{"name":5,"class":6}]