[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592149":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":11,"centralContacts":51,"locations":11,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":11,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,14,17,21,25,28,31,34],{"label":9,"type":10,"description":11,"interventionNames":12},"SYS6002 monotherapy (Q2W)","EXPERIMENTAL",null,[13],"Drug: SYS6002",{"label":15,"type":10,"description":11,"interventionNames":16},"SYS6002 monotherapy (Q3W)",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"JMT101 monotherapy",[20],"Drug: JMT101",{"label":22,"type":10,"description":11,"interventionNames":23},"SYS6002 combinational therapy (Q2W)",[20,13,24],"Drug: SG001",{"label":26,"type":10,"description":11,"interventionNames":27},"SYS6002 combinational therapy (Q3W)",[20,13,24],{"label":29,"type":10,"description":11,"interventionNames":30},"Factorial Group",[13,24],{"label":32,"type":10,"description":11,"interventionNames":33},"Experimental Group 1",[20,13,24],{"label":35,"type":10,"description":11,"interventionNames":36},"Experimental Group 2",[20,13,24],[38,43,47],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":11},"DRUG","JMT101","JMT101 Q2W or Q3W, intravenous injection",[32,35,18,22,26],{"type":39,"name":44,"description":45,"armGroupLabels":46,"otherNames":11},"SYS6002","SYS6002 Q2W or Q3W, intravenous injection",[32,35,29,22,26,9,15],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":11},"SG001","SG001 Q2W or Q3W, intravenous injection",[32,35,29,22,26],[52],{"name":53,"role":54,"phone":55,"phoneExt":11,"email":56},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100592149","phase-2-sys6002-plus-jmt101-and-enlonstobart-injection-in-participants-with-hnscc-100592149",false,"NCT06989671","SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC","A Phase 2 Study of SYS6002 in Combination With JMT101 and Enlonstobart Injection in Participants With Recurrent and\u002For Metastatic Head and Neck Squamous Cell Cancer (HNSCC)","Inclusion Criteria:\n\n* Aged 18 years or older, regardless of gender.\n* Able to understand and voluntarily sign a written informed consent form (ICF).\n* Confirmed recurrent or metastatic HNSCC that is not curable with local treatments. Primary tumor must be located in the oral cavity, oropharynx, hypopharynx, or larynx.\n* Able to provide well-preserved or fresh tumor tissue.\n* According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, at least one measurable lesion confirmed by CT or MRI.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Life expectancy ≥ 3 months.\n* Normal major organ function within 7 days prior to treatment.\n\nExclusion Criteria:\n\n* Primary tumor located in the nasopharynx, nasal cavity, paranasal sinuses, salivary glands, thyroid or parathyroid glands, skin, or squamous cell carcinoma with an unknown primary site.\n* Presence of leptomeningeal metastasis, spinal cord compression, symptomatic or progressive brain metastases.\n* (Only for Stage 2 in Part 2) Prior systemic anti-tumor therapy for recurrent or metastatic HNSCC.\n* Known allergy to any component of SYS6002, JMT101, or Enlonstobart injection.\n* Participants who have previously received MMAE toxin ADC treatment (only for Part 1 and Stage 2 in Part 2).\n* Adverse events related to prior anti-tumor treatment that have not resolved to ≤ Grade 1 according to NCI-CTCAE v5.0 (except for toxicities deemed low-risk by the investigator, such as Grade 2 alopecia).\n* Washout period not met for anti-tumor medications or treatments.\n* Any serious and\u002For uncontrolled comorbid conditions that may interfere with the participant's ability to participate in the study\n* Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test within 7 days before enrollment. Breastfeeding women may participate if they stop breastfeeding, but they cannot resume breastfeeding during the treatment and after the study ends.\n* Any male or female participants of childbearing potential who refuse to use highly effective contraception during the study and for 6 months after the last dose of study drug.\n* Unwilling or unable to comply with the study procedures and requirements, or deemed unsuitable for participation by the investigator.","ALL","18 Years",{"count":69,"type":70},430,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This is a Phase II study of anti-nectin-4 ADC combined with the EGFR monoclonal antibody and the PD-1 monoclonal antibody in participants with advanced head and neck squamous cell carcinoma.",[76],"Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2025-08-20",{"date":80,"type":81},"2025-08-27","ACTUAL",{"date":83,"type":70},"2025-08-30",{"date":85,"type":70},"2028-07-30",{"name":5,"class":6}]