[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633145":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":47,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MRG003 + Epirubicin","EXPERIMENTAL","Participants receive MRG003 (Becotatug vedotin) 2.0 mg\u002Fkg intravenously on day 1 plus epirubicin 75 mg\u002Fm² intravenously on day 1 of each 21-day cycle for 3 cycles.",[13],"Drug: Becotatug Vedotin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Becotatug Vedotin","Becotatug vedotin (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). It consists of a recombinant anti-EGFR humanized monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is administered intravenously at 2.0 mg\u002Fkg on day 1 of each 21-day cycle for 3 cycles.\n\nEpirubicin is an anthracycline chemotherapeutic agent that inhibits topoisomerase II, thereby interfering with DNA replication and transcription. It is administered intravenously at 75 mg\u002Fm² on day 1 of each 21-day cycle for 3 cycles.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Quan Liu, Director","CONTACT","8615001959681","liuqent@163.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Wanpeng Li, mid-level","8613262856870","18879117831@163.com",[32],{"facility":5,"status":33,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Shanghai","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},[44],{"name":45,"role":24,"phone":46,"phoneExt":20,"email":30},"Wanpeng Li, MD","86-13262856870",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Quan Liu","Chief Physician","100633145","phase-2-a-study-of-becotatug-vedotin-mrg003-combined-with-epirubicin-as-neoadjuvant-therapy-for-egfr-positive-unresectable-recurrent-sinonasal-adenoid-cystic-carcinoma-100633145",false,"NCT07522879","A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma","Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study","MRG003-SACC","Inclusion Criteria:\n\nAge ≥ 18 years, male or female. Histopathologically confirmed primary sinonasal adenoid cystic carcinoma (SNACC) that is locally recurrent after prior surgery and\u002For radiotherapy.\n\nEGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.\n\nMultidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.\n\nAt least one measurable lesion in the skull base\u002Fsinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.\n\nWilling to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.\n\nExclusion Criteria:\n\nPrior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.\n\nPrior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.\n\nActive uncontrolled infection, or active autoimmune disease requiring systemic therapy.\n\nSymptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.\n\nKnown severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men\u002Fwomen planning to become pregnant within 6 months after the last dose of study treatment.\n\nAny medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.","ALL","18 Years",{"count":62,"type":63},40,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.",[69,70],"Adenoid Cystic Carcinoma","Sinonasal Carcinoma",[72,73,74,75,76,77,78],"EGFR protein","Unresectable","Adenoid cystic carcinoma","Sinonasal","Becotatug vedotin","Epirubicin","Prospective Studies","2026-05-08",{"date":81,"type":82},"2026-05-12","ACTUAL",{"date":84,"type":63},"2026-05-01",{"date":86,"type":63},"2030-07-01",{"name":5,"class":6},1]