[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452834":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":32,"responsibleParty":197,"collaborators":199,"id":202,"slug":203,"hasResults":204,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":22,"eligibilityCriteria":208,"healthyVolunteers":204,"sex":209,"minAge":210,"maxAge":22,"enrollmentInfo":211,"targetDuration":22,"studyType":214,"phases":215,"briefSummary":218,"conditions":219,"keywords":223,"overallStatus":35,"whyStopped":22,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"Shanghai EpimAb Biotherapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase Ib and Phase II","EXPERIMENTAL","The study will consist of Phase Ib and Phase II. The study is planning to recruit approximately 152 patients in total for advanced\u002Fmetastatic GI cancers, which include 24 patients in Phase Ib and up to approximately 128 patients in Phase II. For GC, HCC, and BTC groups, up to approximately 24 patients may be enrolled in Phase Ib and Phase II. For CRC group, up to approximately 80 patients may be enrolled in Phase Ib and Phase II with up to 40 patients in each subgroup.",[13],"Drug: EMB-01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","EMB-01","EMB-01 at the RP2D of 1600 mg will be administered as an IV infusion once weekly (QW) throughout the study. One cycle is defined as 4 weeks (4 doses).",[9],[21],"FIT-013a",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Rong Wang, M.Sc","CONTACT","+86-21-61043299","CT.info@epimab.com",{"name":30,"role":26,"phone":31,"phoneExt":22,"email":28},"Di Hu, M.Sc","+862161043299",[33,50,65,78,89,100,108,119,130,141,152,164,175,186],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-95.36327,29.76328,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":22,"phoneExt":22,"email":22},"Michael Lee",{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Beijing cancer Hospital","Beijing","Beijing Municipality","100142","China","CN",{"type":42,"coordinates":58},[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63],{"name":64,"role":26,"phone":22,"phoneExt":22,"email":22},"Lin Shen",{"facility":66,"status":35,"city":67,"state":68,"zip":69,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Nanfang Hospital","Guangzhou","Guangdong","510515",{"type":42,"coordinates":71},[72,73],113.25,23.11667,{"lat":73,"lon":72},[76],{"name":77,"role":26,"phone":22,"phoneExt":22,"email":22},"Yabing Guo",{"facility":79,"status":35,"city":80,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hunan Cancer Hospital","Changsha",{"type":42,"coordinates":82},[83,84],112.97087,28.19874,{"lat":84,"lon":83},[87],{"name":88,"role":26,"phone":22,"phoneExt":22,"email":22},"Shanzhi Gu",{"facility":90,"status":35,"city":91,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"West China Hospital, Sichuan University","Chengdu",{"type":42,"coordinates":93},[94,95],104.06667,30.66667,{"lat":95,"lon":94},[98],{"name":99,"role":26,"phone":22,"phoneExt":22,"email":22},"Meng Qiu",{"facility":101,"status":35,"city":67,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"The Sixth Affiliated Hospital of Sun Yat-Sen University",{"type":42,"coordinates":103},[72,73],{"lat":73,"lon":72},[106],{"name":107,"role":26,"phone":22,"phoneExt":22,"email":22},"Yanhong Deng",{"facility":109,"status":35,"city":110,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","Hangzhou",{"type":42,"coordinates":112},[113,114],120.16142,30.29365,{"lat":114,"lon":113},[117],{"name":118,"role":26,"phone":22,"phoneExt":22,"email":22},"Hongming Pan",{"facility":120,"status":35,"city":121,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Harbin Medical University Cancer Hospital","Harbin",{"type":42,"coordinates":123},[124,125],126.65,45.75,{"lat":125,"lon":124},[128],{"name":129,"role":26,"phone":22,"phoneExt":22,"email":22},"Yanqiao Zhang",{"facility":131,"status":35,"city":132,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Shandong Cancer Hospital","Jinan",{"type":42,"coordinates":134},[135,136],116.99722,36.66833,{"lat":136,"lon":135},[139],{"name":140,"role":26,"phone":22,"phoneExt":22,"email":22},"Changzheng Li",{"facility":142,"status":35,"city":143,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Gansu Provincial Hospital","Lanzhou",{"type":42,"coordinates":145},[146,147],103.83987,36.05701,{"lat":147,"lon":146},[150],{"name":151,"role":26,"phone":22,"phoneExt":22,"email":22},"Weisheng Zhang",{"facility":153,"status":154,"city":155,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"The Affiliated hospital of Qingdao University","NOT_YET_RECRUITING","Qingdao",{"type":42,"coordinates":157},[158,159],120.38042,36.06488,{"lat":159,"lon":158},[162],{"name":163,"role":26,"phone":22,"phoneExt":22,"email":22},"Zimin Liu",{"facility":165,"status":35,"city":166,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Fudan University Shanghai Cancer Center","Shanghai",{"type":42,"coordinates":168},[169,170],121.45806,31.22222,{"lat":170,"lon":169},[173],{"name":174,"role":26,"phone":22,"phoneExt":22,"email":22},"Zhiyu Chen",{"facility":176,"status":154,"city":177,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an",{"type":42,"coordinates":179},[180,181],108.92861,34.25833,{"lat":181,"lon":180},[184],{"name":185,"role":26,"phone":22,"phoneExt":22,"email":22},"Enxiao Li",{"facility":187,"status":35,"city":188,"state":22,"zip":22,"country":55,"countryCode":56,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":42,"coordinates":190},[191,192],113.64861,34.75778,{"lat":192,"lon":191},[195],{"name":196,"role":26,"phone":22,"phoneExt":22,"email":22},"Yanru Qin",{"type":198,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[200],{"name":201,"class":6},"Labcorp Corporation of America Holdings, Inc","100452834","phase-1-emb-01-in-patients-with-advancedmetastatic-gastrointestinal-cancers-100452834",false,"NCT05176665","EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Phase Ib\u002FII, Open-Label Study of EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Inclusion Criteria:\n\nMolecular Pre-screening Inclusion criteria\n\n1. cMET amplification in tumor sample; OR\n2. cMET overexpression in tumor sample; OR\n3. EGFR overexpression in tumor sample; OR\n4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).\n\nIn Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR\u002FcMET amplification, overexpression or gene aberration.\n\nScreening Inclusion Criteria\n\n1. Able to understand and willing to sign the Informed Consent Form (ICF).\n2. Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To be eligible, patients must meet following criteria:\n\n   1. Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.\n   2. Have measurable disease as defined by RESIST v 1.1.\n3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.\n4. Must have adequate organ function.\n5. Regarding prior anti-tumor therapy:\n\n   1. Patients who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 4 weeks or within 5 half -lives whichever shorter before first dose of EMB-01.\n   2. Local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.\n   3. Patients who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.\n6. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.\n7. ECOG score ≤1.\n\nExclusion Criteria:\n\nMolecular Pre-screening Exclusion Criteria\n\nSubject who meets any of the following criteria can't be proceeded to clinical screening:\n\n1. Patients who are unwilling to sign the molecular pre-screening ICF.\n2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.\n3. Patients with a documented gene alteration including but not limited to HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistance to EGFR and\u002For cMET inhibitors.\\* \\* In Phase II, CRC patients with activated KRAS, NRAS or BRAF mutation should be excluded, but patients with other gene alterations do not need to be excluded.\n\nScreening Exclusion Criteria\n\n1. Life expectancy \\\u003C 3 months.\n2. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.\n3. Pregnant or nursing females.\n4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.\n5. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.","ALL","18 Years",{"count":212,"type":213},152,"ESTIMATED","INTERVENTIONAL",[216,217],"PHASE1","PHASE2","This study is to evaluate the safety and antitumor activity of EMB-01 in advanced\u002Fmetastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.",[220,221,222],"Neoplasms","Neoplasm Metastasis","Metastatic Gastrointestinal Carcinoid Tumor",[224,225,226,227,221,228],"Human Bispecific antibody","Epidermal Growth Factor Receptor (EGFR)","c-Mesenchymal-Epithelial Transition (cMet)","Neoplasms， Neoplasm Metastasis","EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant","2024-08-22",{"date":231,"type":232},"2024-08-26","ACTUAL",{"date":234,"type":232},"2021-10-21",{"date":236,"type":213},"2025-12-31",{"name":5,"class":6},14]