[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613387":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":56,"locations":62,"responsibleParty":147,"collaborators":149,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":155,"sex":161,"minAge":162,"maxAge":40,"enrollmentInfo":163,"targetDuration":40,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":40,"overallStatus":65,"whyStopped":40,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"A dose escalation of SIM0609","EXPERIMENTAL","Multiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose.",[13],"Drug: SIM0609 for injection",{"label":15,"type":10,"description":16,"interventionNames":17},"A dose expansion of SIM0609 -CRC cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)",[18],"Drug: dose expansion of SIM0609 in CRC",{"label":20,"type":10,"description":21,"interventionNames":22},"A dose expansion of SIM0609-GC\u002FGEJC cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric\u002Fgastroesophageal junction adenocarcinoma (GC\u002FGEJC)",[23],"Drug: dose expansion of SIM0609 in GC\u002FGEJC cohort",{"label":25,"type":10,"description":26,"interventionNames":27},"A dose expansion of SIM0609-PDAC cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC)",[28],"Drug: dose expansion of SIM0609 in PDAC cohort",{"label":30,"type":10,"description":31,"interventionNames":32},"A dose expansion of SIM0609-positive other solid tumors cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors",[33],"Drug: dose expansion of SIM0609 in positive other solid tumors",[35,41,44,48,52],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","SIM0609 for injection","Multiple dose levels of SIM0609 will be explored in dose escalation",[9],null,{"type":36,"name":42,"description":16,"armGroupLabels":43,"otherNames":40},"dose expansion of SIM0609 in CRC",[15],{"type":36,"name":45,"description":46,"armGroupLabels":47,"otherNames":40},"dose expansion of SIM0609 in GC\u002FGEJC cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion in GC\u002FGEJC cohort",[20],{"type":36,"name":49,"description":50,"armGroupLabels":51,"otherNames":40},"dose expansion of SIM0609 in PDAC cohort","1\\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort",[25],{"type":36,"name":53,"description":54,"armGroupLabels":55,"otherNames":40},"dose expansion of SIM0609 in positive other solid tumors","1\\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort",[30],[57],{"name":58,"role":59,"phone":60,"phoneExt":40,"email":61},"Jinxiu Zhang","CONTACT","86-010-65212241","zhangjinxiu@zaiming.com",[63,84,98,111,121,134],{"facility":64,"status":65,"city":66,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Beijing Cancer Hospital","RECRUITING","Beijing","China","CN",{"type":70,"coordinates":71},"Point",[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76,80,82],{"name":77,"role":59,"phone":78,"phoneExt":40,"email":79},"Lin Shen","86-010-88196561","doctorshenlin@sina.cn",{"name":77,"role":81,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"name":83,"role":81,"phone":40,"phoneExt":40,"email":40},"Jian Li",{"facility":85,"status":86,"city":87,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Jiangsu Province Hospital","NOT_YET_RECRUITING","Nanjing",{"type":70,"coordinates":89},[90,91],118.77778,32.06167,{"lat":91,"lon":90},[94],{"name":95,"role":59,"phone":96,"phoneExt":40,"email":97},"Linjun Zhu","+86-13951807457","13951807457@139.com",{"facility":99,"status":86,"city":100,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai",{"type":70,"coordinates":102},[103,104],121.45806,31.22222,{"lat":104,"lon":103},[107],{"name":108,"role":59,"phone":109,"phoneExt":40,"email":110},"Jun Zhang","86-021-64741635","zj10977@rjh.com.cn",{"facility":112,"status":86,"city":100,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Zhongshan Hospital，Fudan University",{"type":70,"coordinates":114},[103,104],{"lat":104,"lon":103},[117],{"name":118,"role":59,"phone":119,"phoneExt":40,"email":120},"Tianshu Liu","+86-13681973996","liu.tianshu@zs-hospital.sh.cn",{"facility":122,"status":86,"city":123,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Tianjin Cancer Hospital","Tianjin",{"type":70,"coordinates":125},[126,127],117.17667,39.14222,{"lat":127,"lon":126},[130],{"name":131,"role":59,"phone":132,"phoneExt":40,"email":133},"Ting Deng","+86-15802243063","xymcdengting@126.com",{"facility":135,"status":86,"city":136,"state":40,"zip":40,"country":67,"countryCode":68,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Hubei Cancer Hospital","Wuhan",{"type":70,"coordinates":138},[139,140],114.26667,30.58333,{"lat":140,"lon":139},[143],{"name":144,"role":59,"phone":145,"phoneExt":40,"email":146},"Xinjun Liang","86-027-8767045","Doctorlxj@163.com",{"type":148,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[150],{"name":151,"class":152},"Shanghai Xianwei Medical Technology Co., Ltd.","UNKNOWN","100613387","phase-1-a-phase-i-study-of-sim0609-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-100613387",false,"NCT07265921","A Phase I Study of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Solid Tumors","Inclusion Criteria:\n\n1. Voluntary participation and signature of informed consent form;\n2. At least 18 years old, male or female;\n3. Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic solid tumors;\n4. Participants should have at least one evaluable or measurable tumor lesion;\n5. Participants have failed the standard of therapy in the locally advanced\u002Fmetastatic setting;\n6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n7. Expected survival ≥12 weeks;\n8. Adequate organ and bone marrow function;\n9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory\n\nExclusion Criteria:\n\n1. Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;\n2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;\n3. Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging screening;\n4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;\n5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;\n7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events);\n8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;\n9. Received prior therapies within the following time frames prior to the first dose of study treatment:\n\n   1. Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.\n   2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).\n   3. Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks.\n   4. Radiation therapy within 4 weeks.\n10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.\n11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n12. Administration of below medications ≤14 days prior to the first dose of study treatment.\n\n    1. Strong or moderate CYP3A4 inducers\u002Finhibitors;\n    2. Drugs with known risk of Torsades de Pointes(TdP);\n    3. Drugs that may prolong the QT interval;\n13. Major surgery within 2 weeks of receiving the first dose of study treatment;\n14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;\n15. Active or chronic hepatitis B or hepatitis C infection;\n16. Participants with clinically significant cardiovascular diseases;\n17. History of allogeneic organ transplantation or graft-versus-host disease;\n18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;\n19. Pregnant or nursing (lactating) women;\n20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;\n21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.","ALL","18 Years",{"count":164,"type":165},232,"ESTIMATED","INTERVENTIONAL",[168],"PHASE1","This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced\u002FMetastatic Solid Tumors",[171],"Advanced Solid Cancer","2025-12-04",{"date":174,"type":175},"2025-12-05","ACTUAL",{"date":177,"type":175},"2025-11-07",{"date":179,"type":165},"2029-06",{"name":5,"class":6},6]