[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486895":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":95,"collaborators":56,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":56,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":56,"enrollmentInfo":106,"targetDuration":56,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":56,"overallStatus":63,"whyStopped":56,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Bio-Thera Solutions","INDUSTRY",[8,14,18,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"A\u002F0.8mg\u002Fkg","EXPERIMENTAL","Drug：BAT8008 for Injection,0.8mg\u002Fkg",[13],"Drug: BAT8008 for Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"B\u002F1.2mg\u002Fkg","Drug：BAT8008 for Injection,1.2mg\u002Fkg",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"C\u002F2.4mg\u002Fkg","Drug：BAT8008 for Injection,2.4mg\u002Fkg",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"D\u002F3.6mg\u002Fkg","Drug：BAT8008 for Injection,3.6mg\u002Fkg",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"E\u002F4.8mg\u002Fkg","Drug：BAT8008 for Injection,4.8mg\u002Fkg",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"F\u002F6.0mg\u002Fkg","Drug：BAT8008 for Injection,6.0mg\u002Fkg",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"G\u002F7.2mg\u002Fkg","Drug：BAT8008 for Injection,7.2mg\u002Fkg",[13],[39],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","BAT8008 for Injection","Intravenous infusion, once every 2 weeks (Q2W). It is recommended that the infusion time of the first cycle should be ≥ 3 hours. If no infusion reaction occurs, the subsequent circulation can be completed within 1-2 hours.",[9,15,19,23,27,31,35],[45],"Recombinant humanized anti Trop2 monoclonal antibody for injection Exetecan conjugate",[47],{"name":48,"affiliation":49,"role":50},"Weier Song","Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","PRINCIPAL_INVESTIGATOR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"WeiNing Li","CONTACT","020-31702863（8028）",null,"wnli@bio-thera.com",{"name":59,"role":54,"phone":56,"phoneExt":56,"email":56},"Zhaohe Wang",[61,81],{"facility":62,"status":63,"city":64,"state":65,"zip":56,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Affiliated Cancer Hospital of Chongqing University","RECRUITING","Chongqing","Chongqing Municipality","China","CN",{"type":69,"coordinates":70},"Point",[71,72],106.55771,29.56026,{"lat":72,"lon":71},[75,79],{"name":76,"role":54,"phone":77,"phoneExt":56,"email":78},"Qi Zhou","86-13708384529","qizhou9128@163.com",{"name":80,"role":50,"phone":56,"phoneExt":56,"email":56},"Yongsheng Li",{"facility":82,"status":63,"city":83,"state":84,"zip":56,"country":66,"countryCode":67,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Zhejiang Cancer Hospital","Hangzhou","Zhejiang",{"type":69,"coordinates":86},[87,88],120.16142,30.29365,{"lat":88,"lon":87},[91,93],{"name":92,"role":54,"phone":56,"phoneExt":56,"email":56},"Weihong Tan",{"name":94,"role":50,"phone":56,"phoneExt":56,"email":56},"Yongling Ji",{"type":96,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100486895","phase-1-evaluate-the-safety-tolerability-and-pharmacokinetic-characteristics-of-bat8008-for-injection-100486895",false,"NCT05620017","Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of BAT8008 for Injection","A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\nAll of the following items could be meet to be enrolled the study\n\n1. Age ≥18 years old, both sexes;\n2. Voluntarily sign the informed consent;\n3. Patients with advanced or metastatic epithelial-derived solid tumors that have been histopathologically or cytologically confirmed, have failed or not been treated with standard therapy, have been intolerant to or have refused standard therapy.\n4. According to RECIST1.1, there is at least one measurable tumor lesion;\n5. The Eastern Collaborative Oncology Group (ECOG) Performance Status score requires a score of 0 or 1;\n6. Investigators assessed the expected survival of ≥12 weeks;\n7. Adequate organ and bone marrow reserve function\n8. Fertile female patients willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period. Male patients must consent to use an effective method of contraception during the study;\n9. Willing to provide previously archived or fresh tumor tissue samples\n10. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures.\n\nExclusion Criteria:\n\nIf you meet any of the following items, you will not be allowed to enroll this study :\n\n1. Within 4 weeks before the first administration of the study drug, he has received experimental drug treatment or participated in clinical research of medical devices;\n2. Have received other anti-tumor treatment within 4 weeks before the first administration of the study drug, such as chemotherapy, radiotherapy (palliative radiotherapy should be completed within 2 weeks before the first administration), targeted therapy\u002Fimmunotherapy (at least 4 weeks or at least 5 half-life, whichever is shorter), hormone therapy (except alternative therapy);\n3. Within 2 weeks before the first administration of the study drug, he has received the treatment of traditional Chinese medicine, Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor effect;\n4. Before the first administration of the study drug, AE (CTCAE5.0) caused by previous anti-tumor treatment was still greater than grade 1, except for the following conditions: a. alopecia; B pigmentation; c. The distal toxicity caused by chemotherapy and radiotherapy can not be further recovered after judgment;\n5. Major surgery (excluding the operation for diagnosis) is required within 4 weeks before the first administration of the study drug or is expected to be performed during the study period;\n6. Patients who have received Trop2 targeted therapy previously;\n7. Those who have received the treatment containing exatecan or irinotecan and other topoisomerase I inhibitor drugs in the past and have experienced drug related AE ≥ grade 3 or treatment failure of topoisomerase I inhibitor;\n8. Have a history of allograft cell or solid organ transplantation;","ALL","18 Years",{"count":107,"type":108},182,"ESTIMATED","INTERVENTIONAL",[111],"PHASE1","Objectives:To evaluate the safety and tolerability of BAT8008 for injection in patients with advanced solid tumors, explore the maximum tolerated dose (MTD), and provide the recommended dose for subsequent clinical trials.",[114],"Advanced Solid Tumors","2026-02-04",{"date":117,"type":118},"2026-02-09","ACTUAL",{"date":120,"type":118},"2022-11-30",{"date":122,"type":108},"2027-05-31",{"name":5,"class":6},2]