[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591112":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":37,"studyPopulation":37,"armGroups":44,"interventions":56,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":95,"collaborators":37,"id":97,"slug":37,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":37,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":79,"whyStopped":37,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Shanghai Miracogen Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival (PFS) as assessed by BIRC","PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.","Baseline to study completion (up to 33 months)",{"measure":14,"description":15,"timeFrame":16},"Overall Survival (OS)","OS is defined as the duration from the start of treatment to death of any cause.","Baseline to study completion (up to 48 months)",[18,21,24,26,30,34],{"measure":19,"description":20,"timeFrame":16},"Objective Response Rate (ORR)","ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.",{"measure":22,"description":23,"timeFrame":16},"Disease Control Rate (DCR)","DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.",{"measure":25,"description":11,"timeFrame":12},"Progression Free Survival (PFS) as assessed by investigator",{"measure":27,"description":28,"timeFrame":29},"Immunogenicity (ADA)","The proportion of patients with positive ADA results.","Baseline to 14 days after the last dose.",{"measure":31,"description":32,"timeFrame":33},"Adverse Events (AEs)","Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.","Baseline to 30 days after the last dose of study treatment",{"measure":35,"description":36,"timeFrame":33},"Serious Adverse Events (SAEs)","Adverse events that are fatal, life-threatening, or result in hospitalization or prolonged hospitalization, persistent or significant disability\u002Fincapacity\u002Fsubstantial disruption of the ability to lead a normal life, congenital anomaly\u002Fbirth defect or major medical events or reactions.",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":37},"NONE",[45,50],{"label":46,"type":47,"description":37,"interventionNames":48},"MRG003 + Pucotenlimab","EXPERIMENTAL",[49],"Drug: MRG003 + Pucotenlimab",{"label":51,"type":52,"description":53,"interventionNames":54},"Chemotherapy Arm","ACTIVE_COMPARATOR","Mono-chemotherapy as selected by investigator",[55],"Drug: Gemcitabine, Docetaxel, or Capecitabine",[57,61],{"type":58,"name":46,"description":59,"armGroupLabels":60,"otherNames":37},"DRUG","MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.",[46],{"type":58,"name":62,"description":63,"armGroupLabels":64,"otherNames":37},"Gemcitabine, Docetaxel, or Capecitabine","Gemcitabine will be administrated via intravenous infusion at 1000 mg\u002Fm2 once on Day 1 and 8 of every 3 weeks (21-day cycle).\n\nDocetaxel will be administrated via intravenous infusion at 75 mg\u002Fm2 once on Day 1 of every 3 weeks (21-day cycle).\n\nCapecitabine will be administrated orally at 1000 mg\u002Fm2 twice a day for Day 1 to 14 of every 3 weeks (21-day cycle).",[51],[66],{"name":67,"affiliation":68,"role":69},"Ruihua Xu, M.D.","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":37,"email":75},"Program Director","CONTACT","86-21-61637960","clinicaltrials@miracogen.com.cn",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":86,"coordinates":87},"Point",[88,89],113.25,23.11667,{"lat":89,"lon":88},[92],{"name":67,"role":73,"phone":93,"phoneExt":37,"email":94},"86-18127912775","xurh@sysucc.org.cn",{"type":96,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100591112",false,"NCT06976190","A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","Magic-C002","Inclusion Criteria:\n\n* Willing to sign the informed consent form and follow the requirements specified in the protocol.\n* Life expectancy ≥ 12 weeks.\n* Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.\n* Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* The score of ECOG for performance status is 0 or 1.\n* No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.\n* Organ functions and coagulation function must meet the basic requirements.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any component of the investigational product.\n* Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.\n* Received anti-infection therapy within 2 weeks prior to the randomization\n* Prior treatment with MMAE\u002FMMAF ADC drugs\n* Central nervous system metastasis.\n* Poorly controlled systemic diseases\n* Patients with poorly controlled heart diseases\n* Poorly controlled pleural and peritoneal effusion or pericardial effusion\n* ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment\n* Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)\n* Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months\n* Received allogeneic tissue\u002Fsolid organ transplantation.\n* Inoculate live vaccine within 30 days before the first dose.\n* Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.\n* History of other primary malignant tumor diseases.\n* Other situations that are not suitable to participate a clinical trial per investigator's judgement","ALL","18 Years","75 Years",{"count":108,"type":109},446,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.",[115],"Recurrent or Metastatic Nasopharyngeal Carcinoma",[117,118,119],"MRG003","Pucotenlimab","Nasopharyngeal Carcinoma","2026-01-16",{"date":122,"type":123},"2026-01-20","ACTUAL",{"date":125,"type":123},"2025-05-06",{"date":127,"type":109},"2030-12",{"name":5,"class":6},1]