[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592149":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":11,"armGroups":38,"interventions":67,"overallOfficials":11,"centralContacts":81,"locations":11,"responsibleParty":87,"collaborators":11,"id":89,"slug":11,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":11,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":11,"enrollmentInfo":97,"targetDuration":11,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":11,"overallStatus":106,"whyStopped":11,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":11},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"Dose-limiting Toxicities (DLTs)",null,"Up to 28 days",{"measure":14,"description":11,"timeFrame":15},"Incidence of Adverse Events (AEs)","Up to approximately 2 years",{"measure":17,"description":11,"timeFrame":15},"Maximum Tolerated Dose (MTD)",{"measure":19,"description":11,"timeFrame":15},"Objective Response Rate (ORR)",[21,23,25,27],{"measure":22,"description":11,"timeFrame":15},"Disease Control Rate (DCR)",{"measure":24,"description":11,"timeFrame":15},"Duration of Response (DOR)",{"measure":26,"description":11,"timeFrame":15},"Progression-free Survival (PFS)",{"measure":28,"description":11,"timeFrame":29},"Overall Survival (OS)","Up to approximately 3 years",{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":11,"timePerspective":11,"maskingInfo":35},"RANDOMIZED","FACTORIAL","Randomized, open-label, factorial design","TREATMENT",{"masking":36,"maskingDescription":11,"whoMasked":11},"NONE","This trial consists of two parts. Part 1 (Monotherapy Group) evaluates both SYS6002 monotherapy (stratified into two cohorts by dose levels and administration frequencies) and JMT101 monotherapy. Part 2 (Combination Therapy Group) comprises Stage 1 (dose escalation phase) and Stage 2 (proof-of-concept phase). Following completion of the dose escalation phase in Part 2 and evaluation of integrated efficacy and safety analyses of SYS6002 monotherapy in Part 1 of this study as well as other clinical studies involving participants with ≥2L HNSCC, the decision on progressing to Stage 2 of Part 2 will be made through discussion between the Sponsor and investigators.",[39,44,47,51,55,58,61,64],{"label":40,"type":41,"description":11,"interventionNames":42},"SYS6002 monotherapy (Q2W)","EXPERIMENTAL",[43],"Drug: SYS6002",{"label":45,"type":41,"description":11,"interventionNames":46},"SYS6002 monotherapy (Q3W)",[43],{"label":48,"type":41,"description":11,"interventionNames":49},"JMT101 monotherapy",[50],"Drug: JMT101",{"label":52,"type":41,"description":11,"interventionNames":53},"SYS6002 combinational therapy (Q2W)",[50,43,54],"Drug: SG001",{"label":56,"type":41,"description":11,"interventionNames":57},"SYS6002 combinational therapy (Q3W)",[50,43,54],{"label":59,"type":41,"description":11,"interventionNames":60},"Factorial Group",[43,54],{"label":62,"type":41,"description":11,"interventionNames":63},"Experimental Group 1",[50,43,54],{"label":65,"type":41,"description":11,"interventionNames":66},"Experimental Group 2",[50,43,54],[68,73,77],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":11},"DRUG","JMT101","JMT101 Q2W or Q3W, intravenous injection",[62,65,48,52,56],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":11},"SYS6002","SYS6002 Q2W or Q3W, intravenous injection",[62,65,59,52,56,40,45],{"type":69,"name":78,"description":79,"armGroupLabels":80,"otherNames":11},"SG001","SG001 Q2W or Q3W, intravenous injection",[62,65,59,52,56],[82],{"name":83,"role":84,"phone":85,"phoneExt":11,"email":86},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":98,"type":99},430,"ESTIMATED","INTERVENTIONAL",[102],"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.",[105],"Head and Neck Squamous Cell Carcinoma","NOT_YET_RECRUITING","2025-08-20",{"date":109,"type":110},"2025-08-27","ACTUAL",{"date":112,"type":99},"2025-08-30",{"date":114,"type":99},"2028-07-30",{"name":5,"class":6}]