[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591112":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai Miracogen Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MRG003 + Pucotenlimab","EXPERIMENTAL",null,[13],"Drug: MRG003 + Pucotenlimab",{"label":15,"type":16,"description":17,"interventionNames":18},"Chemotherapy Arm","ACTIVE_COMPARATOR","Mono-chemotherapy as selected by investigator",[19],"Drug: Gemcitabine, Docetaxel, or Capecitabine",[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","MRG003 will be administrated as specified in the protocol. Pucotenlimab will be administrated as specified in the protocol.",[9],{"type":22,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"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).",[15],[30],{"name":31,"affiliation":32,"role":33},"Ruihua Xu, M.D.","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Program Director","CONTACT","86-21-61637960","clinicaltrials@miracogen.com.cn",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56],{"name":31,"role":37,"phone":57,"phoneExt":11,"email":58},"86-18127912775","xurh@sysucc.org.cn",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100591112","phase-3-a-study-of-mrg003-in-combination-with-pucotenlimab-versus-chemotherapy-in-the-treatment-of-patients-with-recurrent-or-metastatic-nasopharyngeal-carcinoma-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":73,"type":74},446,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80],"Recurrent or Metastatic Nasopharyngeal Carcinoma",[82,83,84],"MRG003","Pucotenlimab","Nasopharyngeal Carcinoma","2026-01-16",{"date":87,"type":88},"2026-01-20","ACTUAL",{"date":90,"type":88},"2025-05-06",{"date":92,"type":74},"2030-12",{"name":5,"class":6},1]