[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594464":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":11,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":11,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":11,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Keymed Biosciences Co.Ltd","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I dose escalation","EXPERIMENTAL",null,[13],"Biological: CM518D1",{"label":15,"type":10,"description":11,"interventionNames":16},"Phase I dose expansion",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Phase II",[13],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BIOLOGICAL","CM518D1","CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.",[9],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).",[15],{"type":22,"name":23,"description":30,"armGroupLabels":31,"otherNames":11},"CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.",[18],[33],{"name":34,"affiliation":35,"role":36},"Ruihua Xu","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Qian Jia","CONTACT","028-88610620","qianjia@keymedbio.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":11,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sun Yat-sen University Cancer Center (SYSUCC)","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58,62],{"name":59,"role":40,"phone":60,"phoneExt":11,"email":61},"Ruihua Xu, Dr.","020-87343468","xurh@sysucc.org.cn",{"name":59,"role":36,"phone":11,"phoneExt":11,"email":11},{"type":64,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100594464","phase-1-study-of-cm518d1-in-patients-with-advanced-solid-tumors-100594464",false,"NCT07019779","Study of CM518D1 in Patients With Advanced Solid Tumors","A Multicenter, Open-Label, Phase I\u002FII Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Male or female ≥ 18 and ≤75 years of age.\n* 2\\. Subjects with histologically or cytologically confirmed advanced solid tumors.\n* 3\\. At least one measurable lesion according to RECIST v1.1.\n* 4\\. Expected survival time ≥ 3 months as judged by the Investigator.\n\nExclusion Criteria:\n\n* 1\\. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).\n* 2\\. Subjects who have received major surgery within 28 days prior to the first dose.\n* 3\\. Subjects who have received radiotherapy within 21 days prior to the first dose.\n* 4\\. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.\n* 5\\. Subjects who have received any CDH17-targeted therapy.\n* 6\\. History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.\n* 7\\. Hypersensitivity to the investigational drug or its excipients.\n* 8\\. Pregnant or lactating female patients.","ALL","18 Years","75 Years",{"count":76,"type":77},434,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.",[84],"Advanced Solid Tumors","2026-06-11",{"date":87,"type":88},"2026-06-15","ACTUAL",{"date":90,"type":88},"2025-06-27",{"date":92,"type":77},"2029-12-31",{"name":5,"class":6},1]