[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631674":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":53,"centralContacts":58,"locations":68,"responsibleParty":90,"collaborators":36,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":36,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":36,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":36,"overallStatus":71,"whyStopped":36,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"JS212 + Capecitabine","EXPERIMENTAL","Participants receive JS212 in combination with Capecitabine.",[13,14],"Drug: JS212","Drug: Capecitabine",{"label":16,"type":10,"description":17,"interventionNames":18},"JS212 +Capecitabine+ Bevacizumab","Participants receive JS212 in combination with Capecitabine and Bevacizumab",[13,14,19],"Drug: Bevacizumab",{"label":21,"type":10,"description":22,"interventionNames":23},"JS212 + XELOX","Participants receive JS212 in combination with XELOX chemotherapy (capecitabine plus oxaliplatin)",[13,14,24],"Drug: Oxaliplatin",{"label":26,"type":10,"description":27,"interventionNames":28},"JS212 + XELOX + JS207","Participants receive JS212 in combination with XELOX chemotherapy and JS207",[13,14,24,29],"Drug: JS207",[31,37,41,45,49],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","JS212","Bispecific antibody-drug conjugate targeting EGFR and HER3",[9,21,26,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Capecitabine","Oral fluoropyrimidine chemotherapy",[9,21,26,16],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Bevacizumab","Humanized anti-VEGF monoclonal antibody",[16],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Oxaliplatin","Platinum-based chemotherapy administered intravenously",[21,26],{"type":32,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"JS207","Bispecific antibody targeting PD-1 and VEGF",[26],[54],{"name":55,"affiliation":56,"role":57},"Zhenyu Xu, Doctor","Medical Director","STUDY_DIRECTOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":36,"email":63},"Ying Zhang, Master","CONTACT","86 18616904609","ying_zhang2@junshipharma.com",{"name":65,"role":61,"phone":66,"phoneExt":36,"email":67},"Huiyu Lan, Master","86 15000239047","huiyu_lan@junshipharma.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200123","China","CN",{"type":78,"coordinates":79},"Point",[80,81],121.45806,31.22222,{"lat":81,"lon":80},[84,88],{"name":85,"role":61,"phone":86,"phoneExt":36,"email":87},"Yong Gao, Ph.D","86 21-38804518","drgaoyong@163.com",{"name":85,"role":89,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"type":91,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100631674","phase-2-js212-combination-therapies-in-metastatic-colorectal-cancer-100631674",false,"NCT07503756","JS212 Combination Therapies in Metastatic Colorectal Cancer","An Open-label, Multicenter Phase 2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JS212 Combination Therapies in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* 1Participants must meet the following key criteria\n* Adults aged 18-75 years with histologically confirmed metastatic colorectal adenocarcinoma\n* Microsatellite stable (MSS) or mismatch repair proficient (pMMR) disease\n* No prior systemic therapy for advanced or metastatic disease\n* At least one measurable lesion according to RECIST v1.1\n* ECOG performance status 0-1\n* Adequate hematologic, hepatic, renal, and coagulation function\n* Life expectancy ≥12 weeks\n* Willingness to provide tumor tissue samples for biomarker analyses\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded\n* Prior treatment with EGFR- or HER3-targeted antibody-drug conjugates or topoisomerase I inhibitor-based ADCs\n* Recent major surgery, radiotherapy, or systemic anticancer therapy prior to study treatment\n* Active or uncontrolled infections or significant cardiovascular disease\n* Known active central nervous system metastases\n* History of autoimmune disease requiring systemic therapy\n* Significant bleeding disorders or high risk of hemorrhage\n* Active viral infections such as uncontrolled hepatitis B, hepatitis C, or HIV\n* Any other serious medical or psychiatric condition that may interfere with study participation","ALL","18 Years","75 Years",{"count":103,"type":104},80,"ESTIMATED","INTERVENTIONAL",[107],"PHASE2","This is an open-label, multicenter Phase 2 clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212-based combination therapies in patients with metastatic colorectal cancer (mCRC).\n\nJS212 is a bispecific antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and HER3 with a topoisomerase I inhibitor payload. Preclinical and early clinical data suggest that dual targeting of EGFR and HER3 may enhance antitumor activity and overcome resistance mechanisms associated with EGFR- or HER2-directed therapies.\n\nThis study will investigate JS212 in combination with capecitabine, with or without Bevacizumab, and JS212 in combination with chemotherapy (XELOX: capecitabine and oxaliplatin), with or without the PD-1\u002FVEGF bispecific antibody JS207, in patients with mCRC.\n\nThe study will assess safety, determine the recommended Phase 3 dose (RP3D), and evaluate preliminary antitumor activity of the combination regimens.",[110],"Metastatic Colorectal Cancer","2026-04-29",{"date":113,"type":114},"2026-05-05","ACTUAL",{"date":116,"type":114},"2026-04-25",{"date":118,"type":104},"2028-03-30",{"name":5,"class":6},1]