[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596821":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":27,"locations":33,"responsibleParty":183,"collaborators":24,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":24,"eligibilityCriteria":191,"healthyVolunteers":187,"sex":192,"minAge":193,"maxAge":24,"enrollmentInfo":194,"targetDuration":24,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":24,"overallStatus":98,"whyStopped":24,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Jiangsu Simcere Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIM0686 momo Dose escalation","EXPERIMENTAL","Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy",[13],"Drug: SIM0686",{"label":15,"type":10,"description":16,"interventionNames":17},"SIM0686 Corhort expansion","Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","SIM0686","Administered intravenously",[15],null,{"type":20,"name":21,"description":22,"armGroupLabels":26,"otherNames":24},[9],[28],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Zhi Zhang","CONTACT","+8618670738874","zhangzhi4@zaiming.com",[34,53,66,81,96,112,127,142,153,168],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Cancer Hospital Chinese Academy of Medical Sciences","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":50,"role":30,"phone":51,"phoneExt":24,"email":52},"Jie Wang, PHD","+8613910704669","zlhuxi@163.com",{"facility":54,"status":36,"city":55,"state":56,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":24,"geoPoint":24,"contacts":58},"Harbin Medical University Cancer Hospital","Haerbin","Heilongjiang","150081",[59,63],{"name":60,"role":30,"phone":61,"phoneExt":24,"email":62},"Tongsen Zheng, PHD","+8615134569619","yqbfzhengtongsen@163.com",{"name":64,"role":65,"phone":24,"phoneExt":24,"email":24},"Yan Yu, PHD","PRINCIPAL_INVESTIGATOR",{"facility":67,"status":36,"city":68,"state":69,"zip":70,"country":40,"countryCode":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital","Zhengzhou","Henan","450003",{"type":43,"coordinates":72},[73,74],113.64861,34.75778,{"lat":74,"lon":73},[77],{"name":78,"role":30,"phone":79,"phoneExt":24,"email":80},"Qiming Wang, PHD","+8613783590691","qimingwang1006@126.com",{"facility":82,"status":36,"city":83,"state":84,"zip":85,"country":40,"countryCode":41,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hunan Cancer Hospital","Changsha","Hunan","410017",{"type":43,"coordinates":87},[88,89],112.97087,28.19874,{"lat":89,"lon":88},[92],{"name":93,"role":30,"phone":94,"phoneExt":24,"email":95},"Zhenyang Liu, PHD","+8618673181133","liuzhenyang@hnca.org.cn",{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":40,"countryCode":41,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Nanjing Tianyinshan Hospital","RECRUITING","Nanjing","Jiangsu","210008",{"type":43,"coordinates":103},[104,105],118.77778,32.06167,{"lat":105,"lon":104},[108],{"name":109,"role":30,"phone":110,"phoneExt":24,"email":111},"Shukui Qin, PHD","+8613905158713","qinsk81@163.com",{"facility":113,"status":36,"city":114,"state":115,"zip":116,"country":40,"countryCode":41,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）","Jinan","Shandong","250117",{"type":43,"coordinates":118},[119,120],116.99722,36.66833,{"lat":120,"lon":119},[123],{"name":124,"role":30,"phone":125,"phoneExt":24,"email":126},"Shuqin Ni, PHD","+8615553115936","nsq163@163.com",{"facility":128,"status":36,"city":129,"state":130,"zip":131,"country":40,"countryCode":41,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Fudan University Shanghai Cancer Center","Shanghai","Shanghai Municipality","200032",{"type":43,"coordinates":133},[134,135],121.45806,31.22222,{"lat":135,"lon":134},[138],{"name":139,"role":30,"phone":140,"phoneExt":24,"email":141},"Jian Zhang, PHD","+8618017312991","syner2000@163.com",{"facility":143,"status":98,"city":129,"state":130,"zip":144,"country":40,"countryCode":41,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Shanghai Gobroad Cancer Hospital","200131",{"type":43,"coordinates":146},[134,135],{"lat":135,"lon":134},[149],{"name":150,"role":30,"phone":151,"phoneExt":24,"email":152},"Jin Lin, PHD","+8613761222111","jin.li@gobroadhealthcare.com",{"facility":154,"status":98,"city":155,"state":156,"zip":157,"country":40,"countryCode":41,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Sichuan Cancer Hospital","Chengdu","Sichuan","610040",{"type":43,"coordinates":159},[160,161],104.06667,30.66667,{"lat":161,"lon":160},[164],{"name":165,"role":30,"phone":166,"phoneExt":24,"email":167},"Tongyu Lin, PHD","+8613926400320","lintongyu@scszlyy.org.cn",{"facility":169,"status":36,"city":170,"state":171,"zip":172,"country":40,"countryCode":41,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Tianjin Cancer Hospital","Tianjin","Tianjin Municipality","300060",{"type":43,"coordinates":174},[175,176],117.17667,39.14222,{"lat":176,"lon":175},[179],{"name":180,"role":30,"phone":181,"phoneExt":24,"email":182},"Ting Deng, PHD","+8615802243063","xymcdengting@126.com",{"type":184,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100596821","phase-1-a-phase-i-study-of-sim0686-in-participants-with-locally-advancedmetastatic-solid-tumors-100596821",false,"NCT07050459","A Phase I Study of SIM0686 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Voluntary participation and signature of informed consent form;\n* At least 18 years old, male, or female;\n* Participants with histologically and\u002For cytologically confirmed locally advanced\u002Fmetastatic solid tumors;\n* Participants should have at least one evaluable or measurable tumor lesion (RECIST v1.1);\n* Participants have failed the standard of therapy in the locally advanced\u002Fmetastatic setting\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;\n* Expected survival ≥12 weeks;\n* Adequate organ and bone marrow function;\n* Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 6 months before first administration for evaluation of FGFR2b expression levels\n\nExclusion Criteria:\n\n* 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.\n* Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.\n* Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.\n* 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.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.\n* Has 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 (e.g., tyrosine kinase inhibitors) 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.\n* Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.\n* Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n* Active or chronic hepatitis B or hepatitis C infection;","ALL","18 Years",{"count":195,"type":196},220,"ESTIMATED","INTERVENTIONAL",[199],"PHASE1","This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced\u002FMetastatic Solid Tumors",[202],"Locally Advanced Solid Tumors","2025-07-02",{"date":205,"type":206},"2025-07-03","ACTUAL",{"date":208,"type":206},"2025-05-20",{"date":210,"type":196},"2028-12",{"name":5,"class":6},10]