[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612244":3},{"organization":4,"outcomesModule":7,"designInfo":96,"detailedDescription":108,"studyPopulation":95,"armGroups":109,"interventions":137,"overallOfficials":95,"centralContacts":153,"locations":95,"responsibleParty":159,"collaborators":95,"id":161,"slug":95,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":95,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":95,"studyType":173,"phases":174,"briefSummary":177,"conditions":178,"keywords":95,"overallStatus":180,"whyStopped":95,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":95},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":36,"otherOutcomes":95},[9,13,17,21,24,28,32],{"measure":10,"description":11,"timeFrame":12},"PhaseII(safety leadrun-in stage): DLT; Description: Dose-limiting toxicity","Dose-limiting toxicity","28 days",{"measure":14,"description":15,"timeFrame":16},"PhaseII(safety run-inlead-in stage): AE","The incidence and severity of Adverse events","From the signing of the informed consent form until 90 days after the last dose.",{"measure":18,"description":19,"timeFrame":20},"PhaseII(safety leadrun-in stage): MTD;","Maximum tolerated dose","After phase II saftysafety run-inlead-in stage and dose expansion stage. Approximately 4 months.",{"measure":22,"description":23,"timeFrame":20},"PhaseII(safety run-inlead-in stage): RP2D","Recommended Phase II dose",{"measure":25,"description":26,"timeFrame":27},"PhaseII(Randomized treatment stage): ORR per RECIST v1.1","Objective response rate","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.",{"measure":29,"description":30,"timeFrame":31},"PhaseIII: PFS-ICR","PFS assessed by independent review committee","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years",{"measure":33,"description":34,"timeFrame":35},"PhaseIII: OS;","Overall survival","Through study completion, up to approximately 5 year.",[37,40,43,46,49,53,56,59,62,65,69,73,75,78,82,84,87,90,92],{"measure":38,"description":39,"timeFrame":31},"Phase II: DOR per RECIST 1.1;","Duration of response.",{"measure":41,"description":42,"timeFrame":31},"Phase II: DCR per RECIST 1.1;","Disease of controll",{"measure":44,"description":45,"timeFrame":31},"Phase II:PFS per RECIST 1.1","Progression free survival",{"measure":47,"description":34,"timeFrame":48},"Phase II:OS","Through study completion, up to approximately 5 year",{"measure":50,"description":51,"timeFrame":52},"Phase II: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010","Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010","From first dose of treatment to 30 days after the last dose of treatment.",{"measure":54,"description":55,"timeFrame":52},"Phase II: plasma concentration of SG001 following single and multiple doses of SG001;","Plasma concentration of SG001 following single and multiple doses of SG001",{"measure":57,"description":58,"timeFrame":52},"Phase II: EGFR protein expression and PD-L1 protein expression;","EGFR protein expression and PD-L1 protein expression;",{"measure":60,"description":61,"timeFrame":52},"Phase II: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010.","The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010.",{"measure":63,"description":64,"timeFrame":52},"Phase II: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001;","The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001.",{"measure":66,"description":67,"timeFrame":68},"Phase III: DOR-IRC per RECIST 1.1","Duration of response assessed by independent review committee","Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12 weeks thereafter, until the end of the study",{"measure":70,"description":71,"timeFrame":72},"Phase III: DCR-IRC per RECIST 1.1;","Disease of controll assessed by independent review committee.","Weeks 8, 12, 18, every 6 weeks within 48 weeks, and every 12",{"measure":74,"description":45,"timeFrame":27},"Phase III:PFS per RECIST 1.1;",{"measure":76,"description":77,"timeFrame":27},"Phase III:ORR-IRC;","Objective response rate assessed by independent review committee",{"measure":79,"description":80,"timeFrame":81},"Phase III: AE;","Incidence and severity of adverse events","From first dose of treatment to 90 days after the last dose of treatment.",{"measure":83,"description":51,"timeFrame":52},"Phase III: Serum concentrations of toxin-bound antibodies, total antibodies, and JS-1 following single and multiple doses of SYS6010;",{"measure":85,"description":55,"timeFrame":86},"Phase III: plasma concentration of SG001 following single and multiple doses of SG001","From first dose of treatment to 30 days after the last dose of treatment.From first dose of treatment to 30 days after the last dose of treatment.",{"measure":88,"description":89,"timeFrame":52},"Phase III: EGFR protein expression and PD-L1 protein expression","EGFR protein expression and PD-L1 protein expression",{"measure":91,"description":61,"timeFrame":52},"Phase III: The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SYS6010 .",{"measure":93,"description":93,"timeFrame":94},"The incidence and titer of anti-drug antibodies (ADA), as well as the incidence of neutralizing antibodies (NAb) (if applicable), for SG001","From first dose of treatment to 30 days after the last dose of treatment",null,{"allocation":97,"interventionModel":98,"interventionModelDescription":99,"primaryPurpose":100,"observationalModel":95,"timePerspective":95,"maskingInfo":101},"RANDOMIZED","SEQUENTIAL","This is a Phase II\u002FIII study. Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.","TREATMENT",{"masking":102,"maskingDescription":95,"whoMasked":103},"QUADRUPLE",[104,105,106,107],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Phase II study comprises a safety lead-in stage, a dose expansion stage, and a randomized treatment stage. The Phsae III study is randomized controlled trial.\n\nPhase II (safety lead-in stage): the safety lead-in stage employs a 3+3 design. It aims to evaluate the safety and tolerability of combination therapy-comprising capecitabine\u002F5-FU administered at a descending dose level starting from DL0 alongside fixed doses of SYS6010 and SG001-in previously untreated patients with unresectable locally advanced or metastatic ESCC. The primary objectives are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D).\n\nPhase II (dose expansion stage): Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety lead-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.\n\nPhase II (randomized treatment stage): Upon determination of the RP2D based on prior data, a randomized controlled study will be conducted in a first-line advanced\u002Fmetastatic esophageal squamous cell carcinoma (ESCC) patient population. Patients will be randomly assigned to three arms: Arm 1: SYS6010+SG001+ capecitabine\u002F5-FU; arm2: investigator's choice of SOC; arm3: SYS6010+SG001.\n\nPhase III is a randomized, controlled, open-label, multicenter study designed to evaluate the efficacy of SYS6010+SG001+capecitabine\u002F5-FU versus investigator's choice of treatment as first-line therapy for advanced\u002Fmetastatic esophageal squamous cell carcinoma. The Phase III trial design will be finalized based on Phase II results. The preliminary plan is to randomized patients in a 1:1 ratio to either the investigational arm or the control arm. Investigational arm: SYS6010+SG001+capecitabine\u002F5-FU; control arm: investigator's choice of SOC.",[110,115,119,122,127,131,134],{"label":111,"type":112,"description":95,"interventionNames":113},"Phase II (Safety lead-in stage) : SYS6010+SG001+physician's choice(Capecitabine or 5-FU )","EXPERIMENTAL",[114],"Drug: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",{"label":116,"type":112,"description":117,"interventionNames":118},"Phase II (dose expansion stage): SYS6010+SG001+physician's choice (Capecitabine or 5-FU)","Upon completion of the safety evaluation and confirmation of tolerability for a dose cohort in the safety run-in phase, expansion of that cohort may be initiated, with plans to expand 1-2 dose cohorts.",[114],{"label":120,"type":112,"description":95,"interventionNames":121},"Phase II(randomized Controlled stage): SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",[114],{"label":123,"type":124,"description":95,"interventionNames":125},"PhaseII(randomized treatment stage): physician's choice of SOC","ACTIVE_COMPARATOR",[126],"Drug: Investigator's choice of SOC",{"label":128,"type":112,"description":95,"interventionNames":129},"Phase II(randomized controlled stage): SYS6010+SG001",[130],"Drug: SYS6010+SG001",{"label":132,"type":124,"description":95,"interventionNames":133},"Phase III: SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)",[114],{"label":135,"type":124,"description":95,"interventionNames":136},"Phase III: physician's choice of SOC",[126],[138,145,149],{"type":139,"name":140,"description":141,"armGroupLabels":142,"otherNames":143},"DRUG","SYS6010+SG001+ physician's choice (Capecitabine or 5-FU)","SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker.\n\nSG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody. Capecitabine: Capecitabine is for oral administration. 5-FU: Administration at the conventional dosage.",[111,116,120,132],[144],"SG001: Enlonstobart",{"type":139,"name":146,"description":147,"armGroupLabels":148,"otherNames":95},"Investigator's choice of SOC","1. Camrelizumab + Cisplatin + Paclitaxel\n2. Tislelizumab + Cisplatin + Paclitaxel\n3. Tislelizumab + Cisplatin + 5-FU\u002FCapecitabine",[135,123],{"type":139,"name":150,"description":151,"armGroupLabels":152,"otherNames":95},"SYS6010+SG001","SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker.\n\nSG001 is a recombinant, fully human, anti-PD-1 monoclonal antibody.",[128],[154],{"name":155,"role":156,"phone":157,"phoneExt":95,"email":158},"Clinical Trials Information Group officer","CONTACT","0311-69085587","ctr-contact@cspc.cn",{"type":160,"investigatorFullName":95,"investigatorTitle":95,"investigatorAffiliation":95,"oldNameTitle":95,"oldOrganization":95},"SPONSOR","100612244",false,"NCT07251062","A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.","A Phase II\u002FIII Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU\u002FCapecitabine in Subjects With First-Line Advanced\u002FMetastatic Esophageal Squamous Cell Carcinoma.","Inclusion Criteria:\n\n1. Be able to understand and voluntarily sign the written ICF;\n2. Age 18-75 (inclusive) years, male or female;\n3. With histologically\u002Fcytologically confirmed esophageal squamous cell carcinoma that is either locally advanced unresectable or metastatic, with no prior systemic antitumor therapy administered for the recurrent\u002Fmetastatic disease setting. Have at least one measurable lesion that meets the RECIST v 1.1 criteria at baseline;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;\n5. Life expectancy ≥ 3 months;\n\nExclusion Criteria:\n\n1. Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);\n2. Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory\u002Fco-inhibitory pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 antibodies)\n3. With a history of ≥Grade 3 allergic reactions to monoclonal antibodies, or with known hypersensitivity or intolerance to SYS6010, SG001, paclitaxel, carboplatin, cisplatin, fluorouracil, or any of their excipients;\n4. With dihydropyrimidine dehydrogenase (DPD) deficiency.","ALL","18 Years","75 Years",{"count":171,"type":172},737,"ESTIMATED","INTERVENTIONAL",[175,176],"PHASE2","PHASE3","This is a multicenter phase 2\u002F3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU\u002FCapecitabine as first-line treatment, in patients with advanced\u002Fmetastatic esophageal squamous cell carcinoma.",[179],"Esophageal Squamous Cell Carcinoma","NOT_YET_RECRUITING","2025-11-18",{"date":183,"type":184},"2025-11-26","ACTUAL",{"date":186,"type":172},"2025-12-30",{"date":188,"type":172},"2030-12-30",{"name":5,"class":6}]