[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650574":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":51,"centralContacts":76,"locations":84,"responsibleParty":103,"collaborators":51,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":51,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":51,"enrollmentInfo":114,"targetDuration":51,"studyType":117,"phases":118,"briefSummary":121,"conditions":122,"keywords":51,"overallStatus":124,"whyStopped":51,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,14,19,24,29,34,39],{"label":9,"type":10,"description":11,"interventionNames":12},"Ib-Randomized Arm 1","EXPERIMENTAL","Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level A in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.",[13],"Drug: SYS6090 (Fixed Dose Level A) + bevacizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Ib-Randomized Arm 2","Enrolled Subjects will be randomized to receive SYS6090 at the fixed dose level B in combination with bevacizumab. The exact dose magnitude and administration frequency of SYS6090 are temporarily undisclosed to protect pending patent information, with full dosing details archived in platform backend for regulatory review only.",[18],"Drug: SYS6090 (Fixed Dose Level B ) + bevacizumab",{"label":20,"type":10,"description":21,"interventionNames":22},"II-Cohort 1- Randomized Arm A","Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and mFOLFOX6",[23],"Drug: SYS6090 RP2D + bevacizumab +mFOLFOX6",{"label":25,"type":10,"description":26,"interventionNames":27},"II-Cohort 1- Randomized Arm B","Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab",[28],"Drug: SYS6090 RP2D + bevacizumab",{"label":30,"type":10,"description":31,"interventionNames":32},"II-Cohort 1- Randomized Arm C","Enrolled Subjects will be randomized to receive regorafenib",[33],"Drug: Regorafenib",{"label":35,"type":10,"description":36,"interventionNames":37},"II-Cohort 2- Randomized Arm D","Enrolled Subjects will be randomized to receive SYS6090 at RP2D combined with bevacizumab and FOLFOXIRI",[38],"Drug: SYS6090 PR2D+ bevacizumab + FOLFOXIRI",{"label":40,"type":41,"description":42,"interventionNames":43},"II-Cohort 2- Randomized Arm E","ACTIVE_COMPARATOR","Enrolled Subjects will be randomized to receive bevacizumab combined with FOLFOXIRI",[44],"Drug: bevacizumab + FOLFOXIRI",[46,52,56,60,64,68,72],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","SYS6090 (Fixed Dose Level A) + bevacizumab","Participants will receive intravenous SYS6090 at fixed dose level A combined with intravenous bevacizumab, administered per cycle schedule specified in study protocol, for advanced\u002Fpalliative unresectable pMMR\u002FMSS colorectal cancer.",[9],null,{"type":47,"name":53,"description":54,"armGroupLabels":55,"otherNames":51},"SYS6090 (Fixed Dose Level B ) + bevacizumab","Participants will receive intravenous SYS6090 at fixed dose level B plus intravenous bevacizumab per protocol-defined cycle schedule for unresectable advanced pMMR\u002FMSS colorectal cancer.",[15],{"type":47,"name":57,"description":58,"armGroupLabels":59,"otherNames":51},"SYS6090 RP2D + bevacizumab +mFOLFOX6","Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab combined with standard mFOLFOX6 chemotherapy regimen (oxaliplatin, leucovorin, fluorouracil), administered per protocol-defined cycle schedule for unresectable advanced pMMR\u002FMSS colorectal cancer.",[20],{"type":47,"name":61,"description":62,"armGroupLabels":63,"otherNames":51},"SYS6090 RP2D + bevacizumab","Participants will receive intravenous SYS6090 at RP2D plus intravenous bevacizumab, administered per protocol-defined cycle schedule for unresectable advanced pMMR\u002FMSS colorectal cancer.",[25],{"type":47,"name":65,"description":66,"armGroupLabels":67,"otherNames":51},"Regorafenib","Oral regorafenib monotherapy as standard control for metastatic pMMR\u002FMSS colorectal cancer.",[30],{"type":47,"name":69,"description":70,"armGroupLabels":71,"otherNames":51},"SYS6090 PR2D+ bevacizumab + FOLFOXIRI","Participants will receive intravenous SYS6090at RP2D plus intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR\u002FMSS colorectal cancer.",[35],{"type":47,"name":73,"description":74,"armGroupLabels":75,"otherNames":51},"bevacizumab + FOLFOXIRI","Participants will receive intravenous bevacizumab combined with FOLFOXIRI triple chemotherapy (oxaliplatin, irinotecan, leucovorin, fluorouracil) per study cycle schedule for metastatic pMMR\u002FMSS colorectal cancer.",[40],[77,82],{"name":78,"role":79,"phone":80,"phoneExt":51,"email":81},"Clinical Trials Information Group officer","CONTACT","0311-69085587","ctr-contact@cspc.cn",{"name":83,"role":79,"phone":51,"phoneExt":51,"email":51},"LIN",[85],{"facility":86,"status":51,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Fujian Cancer Hospital","Fujian","Fuzhou","350014","China","CN",{"type":93,"coordinates":94},"Point",[95,96],106.12972,28.92651,{"lat":96,"lon":95},[99],{"name":100,"role":79,"phone":101,"phoneExt":51,"email":102},"Rong-Bo Lin, PhD","+86 13705919382","linrongbo@fjzlhospital.com",{"type":104,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100650574","phase-1-a-phase-ibii-study-of-sys6090-combination-therapy-in-advanced-colorectal-cancer-100650574",false,"NCT07750041","A Phase Ib\u002FII Study of SYS6090 Combination Therapy in Advanced Colorectal Cancer","A Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Efficacy of SYS6090 in Combination With Other Therapies in Participants With Advanced Coloretal Cancer","\\*Eligibility Criteria:\n\nInclusion Criteria:\n\n1. Subjects must be ≥18 years of age.\n2. Histologically or cytologically confirmed unresectable advanced or metastatic colorectal cancer with pMMR\u002FMSS status, assigned to corresponding cohorts as follows:\n\n   Cohort 1 (2L\u002F3L) of Phase Ib \\& Phase II: Subjects must have disease progression after no more than 2 lines of standard systemic therapy (prior regimens must contain fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy); tumor tissue confirmed as pMMR by IHC or MSS by NGS\u002FPCR; Cohort 2 (1L) of Phase Ib \\& Phase II: Subjects have received no prior systemic anti-tumor therapy for advanced disease; tumor tissue confirmed as pMMR by IHC or MSS by NGS\u002FPCR.\n3. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Expected survival ≥ 3 months.\n6. Has protocol-defined adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Subjects with clinically active central nervous system metastases;\n2. with a history of other primary malignant tumors within 5 years before administration;\n3. Subjects assigned to Cohort 1 who have received prior regorafenib treatment.;\n4. Prior documented interstitial lung disease (ILD)\u002F pneumonitis that required steroids, current ILD\u002F pneumonitis, or suspected ILD\u002F pneumonitis that cannot be ruled out by imaging at screening;\n5. Uncontrolled or significant cardiovascular disease;\n6. Clinically uncontrolled pleural effusion, ascites or pericardial effusion;\n7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to Grade ≤ 1 or baseline .","ALL","18 Years",{"count":115,"type":116},260,"ESTIMATED","INTERVENTIONAL",[119,120],"PHASE1","PHASE2","This study constitutes an open-label, multi-cohort, multi-center Phase Ib\u002FII clinical study, developed to assess the safety, tolerability, and therapeutic efficacy of SYS6090 injection when administered in combination with bevacizumab, or in triple combination with bevacizumab and chemotherapy, among patients diagnosed with advanced colorectal cancer.",[123],"Unresectable Advanced or Metastatic Colorectal Cancer","NOT_YET_RECRUITING","2026-08-02",{"date":127,"type":128},"2026-08-06","ACTUAL",{"date":130,"type":116},"2026-08-30",{"date":132,"type":116},"2029-08-30",{"name":5,"class":6},1]