[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498721":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":19,"responsibleParty":50,"collaborators":11,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":11,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"9MW2821","EXPERIMENTAL",null,[13],"Drug: 9MW2821",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).",[9],[20,40],{"facility":21,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":29,"coordinates":30},"Point",[31,32],116.39723,39.9075,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Jun Guo, Professor","CONTACT","13911233048","guoj307@126.com",{"facility":41,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":42,"geoPoint":44,"contacts":45},"Beijing University Cancer Hospital",{"type":29,"coordinates":43},[31,32],{"lat":32,"lon":31},[46,48],{"name":36,"role":37,"phone":47,"phoneExt":11,"email":39},"139 1123 3048",{"name":36,"role":49,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":51,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100498721","phase-1-a-clinical-study-of-9mw2821-in-advanced-malignant-solid-tumors-100498721",false,"NCT05773937","A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors","A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.\n* Subjects must have received ICIs or GC\u002FGP therapies in the previous treatment.\n* Subjects must submit tumor tissues for test.\n* Life expectancy of ≥ 3 months.\n* Subjects must have measurable disease according to RECIST (version 1.1).\n* Adequate organ functions.\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.\n* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).\n* Major surgery within 28 days prior to first dose of study drug.\n* History of uncontrolled diabetes mellitus.\n* Preexisting peripheral neuropathy Grade ≥ 2.\n* Received treatment of ADCs with MMAE payload.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n* Uncontrolled central nervous system metastases.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n* Has ocular conditions that may increase the risk of corneal epithelium damage.\n* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or CYP3A4 inducers\u002Finhibitors for high and medium effect within 14 days prior to the first dose of study drug.\n* Use of any investigational drug or device within 30 days prior to the first dose of study drug.\n* Conditions or situations which may put the subject at significant risk.","ALL","18 Years","80 Years",{"count":63,"type":64},40,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.",[70],"Advanced Malignant Solid Tumors","2024-09-09",{"date":73,"type":74},"2024-09-19","ACTUAL",{"date":76,"type":74},"2022-06-21",{"date":78,"type":64},"2024-12-31",{"name":5,"class":6},2]