[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557709":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":46,"locations":54,"responsibleParty":87,"collaborators":90,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":33,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":33,"enrollmentInfo":105,"targetDuration":33,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":57,"whyStopped":33,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Peking University","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation Level 1","EXPERIMENTAL","EVM16 dose level 1 as single and combined therapy with Tislelizumab.",[13,14],"Biological: EVM16","Drug: Tislelizumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose Escalation Level 2","EVM16 dose level 2 as single and combined therapy with Tislelizumab.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Escalation Level 3","EVM16 dose level 3 as single and combined therapy with Tislelizumab.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Expansion","EVM16 RP2D dose in combination with Tislelizumab.",[13,14],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","EVM16","cancer vaccine",[9,16,20,24],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","Tislelizumab","Anti-PD1 antibody",[9,16,20,24],[40],"Tevimbra",[42],{"name":43,"affiliation":44,"role":45},"Lin Shen, MD","Peking University Cancer Hospital & Institute","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":33,"email":50},"CONTACT","+8601088196561","linshenpkn@163.com",{"name":52,"role":48,"phone":49,"phoneExt":33,"email":53},"Yanshuo Cao, MD","yanshuo.cao@bjmu.edu.cn",[55,72],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Beijing Cancer Hospital","RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":64,"coordinates":65},"Point",[66,67],116.39723,39.9075,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":49,"phoneExt":33,"email":50},"Lin Shen",{"facility":73,"status":57,"city":74,"state":75,"zip":76,"country":61,"countryCode":62,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200135",{"type":64,"coordinates":78},[79,80],121.45806,31.22222,{"lat":80,"lon":79},[83],{"name":84,"role":48,"phone":85,"phoneExt":33,"email":86},"Jian Zhang","+8602164175590","syner2000@163.com",{"type":45,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":44,"oldNameTitle":33,"oldOrganization":33},"Shen Lin","Prof.",[91,93],{"name":92,"class":6},"Shanghai Cancer Centre",{"name":94,"class":95},"Everest Medicines (China) Co.,Ltd.","INDUSTRY","100557709","phase-1-evm16-injection-as-a-single-and-combination-with-tislelizumab-in-solid-tumors-100557709",false,"NCT06541639","EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors","A Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Initial Efficacy of EVM16 Injection as a Single and Combination With Tislelizumab in Subjects With Advanced or Recurrent Solid Tumors","Key Inclusion Criteria:\n\n* Recurrent or metastatic solid tumors that have been histologically or cytologically pathologically confirmed and are not amenable to radical treatment with surgery or local therapy.\n* Patients with advanced or recurrent solid tumors who have failed prior standard therapy.\n* Expected survival period \\>6 weeks at the time of informed consent.\n* Adequate organ function\n* Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0 to 1.\n* Is willing to provide archival or fresh tumor tissue samples for EVM16 production.\n* Has adequate treatment washout period prior to first study dose.\n* Has at least one measurable lesion as assessed by the investigator according to RECIST version 1.1 criteria before enrollment.\n\nKey Exclusion Criteria:\n\n* Primary central nervous system (CNS) malignancies that are symptomatic, untreated, or in need of curative treatment, or subjects with CNS metastases.\n* Uncontrolled co-morbidities.\n* Cerebrovascular event (stroke, transient ischemic attack, etc.) within 4 months prior to the signing of inform consent form.\n* In screening period male QTcF interval \\>450 ms; Female QTcF interval \\>470 ms (calculated by the Fridericia formula).\n* Left ventricular ejection fraction (LVEF) \\\u003C 50% during the screening period.\n* Diagnosis of immunodeficiency, or history or syndrome of active as well as former autoimmune disease with risk of relapse, or a disease requiring systemic steroid hormone or immunosuppressive drug therapy.\n* Subjects with a history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS).\n* Co-infection HBV and HCV.\n* Presence of any active infection requiring systemic therapy.\n* Patients who are still on any other investigational medications treatment at the time of screening.\n* Previous treatment with cell therapy, tumor vaccines, cytokines, or growth factors for cancer control.\n* Patients with prior intolerance to tislelizumab resulting in permanent termination of tislelizumab.\n* History or presence of significant lung disease.","ALL","18 Years",{"count":106,"type":107},78,"ESTIMATED","INTERVENTIONAL",[110],"PHASE1","The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) . This clinical trial will include solid tumor patients who failed standard treatment.\n\nThe main questions to answer are:\n\nSafety of EVM16. Suitable dose of EVM16. Effects of EVM16 combined with tislelizumab.",[113],"Advanced or Recurrent Solid Tumors",[115,116,117],"solid tumor","tumor vaccine","immune checkpoint inhibitor","2026-06-17",{"date":120,"type":121},"2026-06-22","ACTUAL",{"date":123,"type":121},"2025-03-04",{"date":125,"type":107},"2028-12",{"name":5,"class":6},2]