[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Bao Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100595725","phase-1-a-clinical-trail-of-kj015-in-patients-with-her2-expressing-solid-tumors-100595725",false,"NCT07036185","A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors","An Open-Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of KJ015 Injection (Subcutaneous Injection) in Patients With HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n1. Aged ≥ 18 years (at time of free and informed consent).\n2. Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.\n4. Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital\n5. Organ function must meet the following criteria:\n\n   i.Hemoglobin (Hb) ≥ 9.0 g\u002FdL ii.Absolute neutrophil count (ANC) ≥ 1.0 × 109\u002FL iii.Platelet count (PLT) ≥ 80 × 109\u002FL v.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver lesions (primary or metastatic); ALT and AST ≤ 5 × ULN if liver lesions are present vi.Creatinine clearance ≥ 30 mL\u002Fmin vii.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN viii. Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL).\n6. Expected survival ≥ 3 months.\n7. Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.\n\nExclusion Criteria:\n\n1. Concurrent participation in another clinical study.\n2. Received radiotherapy within 2 weeks prior to the first dose.\n3. Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.\n4. Prior allogeneic bone marrow transplant or prior solid organ transplant.\n5. Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.\n6. Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg\u002Fm2 or an equivalent dose of other anthracyclines prior to the first dose.\n7. History of leptomeningeal carcinomatosis or carcinomatous meningitis.\n8. Brain metastasis or spinal cord compression.\n9. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.\n10. History of a serious allergic reaction to the investigational product, an inactive ingredient in the investigational product, or other monoclonal antibody.\n11. Women who are pregnant or breastfeeding as confirmed by pregnancy testing within 3 days prior to first dose.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.",[26,27,28,29,30,31],"Gastric\u002FGastroesophageal Junction Cancer","Breast Cancer","Colorectal Cancer","Non-small Cell Lung Cancer (NSCLC)","Bile Duct Cancer","Head and Neck Squamous Cell Carcinoma",[33,34,35],"KJ015","HER2","solid tumors","NOT_YET_RECRUITING","2025-06-16",{"date":39,"type":40},"2025-06-25","ACTUAL",{"date":42,"type":20},"2025-06-24",{"date":44,"type":20},"2027-04-30",{"name":46,"class":47},"Shanghai Bao Pharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100594896","phase-2-phase-ii-clinical-trial-of-kj101in-the-treatment-of-deep-ii-degree-burns-100594896","NCT07025408","Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns","A Multicentre, Randomised, Double-blind, Dose-exploratory, Controlled Drug and Placebo-controlled Phase II Clinical Trial Evaluating the Safety, Efficacy, Pharmacokinetic Profile, and Immunogenicity of KJ101 for Wound Debridement in Deep II Degree Burns","Inclusion criteria:\n\n1. Male and female subjects aged 18 to 65 years inclusive, who are neither pregnant nor lactating;\n2. Clinically diagnosed with superficial or deep II degree burns within 72 hours of injury, with a total burn area of ≤30% TBSA. The target burn wound must be isolated or have distinguishable boundaries, with an area between 40 and 200 cm².\n3. Subjects of childbearing age must agree to use effective and safe contraceptive methods during the treatment period and for three months after the final administration.\n\nExclusion criteria:\n\n1. Individuals who are known to be allergic to any component of the test drug or who have a tendency to allergies.\n2. Burns caused by specific factors, such as electrical or chemical burns.\n3. Subjects with shock or inhalation lung injury;\n4. Subjects with target wounds complicated by inflammatory skin diseases (e.g. atopic dermatitis, eczema or psoriasis), or who have undergone enzymatic debridement (e.g. with collagenase, papain, bromelain, chymotrypsin or trypsin).\n5. Subjects who, during screening, are judged by the investigator to have other severe systemic infections requiring systemic treatment;\n6. Abnormal liver or kidney function.","65 Years",{"count":58,"type":20},144,[60],"PHASE2","This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.",[63,64],"Burn","Burn Wounds - Partial Thickness (2nd Degree)","RECRUITING","2025-06-10",{"date":68,"type":40},"2025-06-17",{"date":37,"type":20},{"date":71,"type":20},"2026-08-29",{"name":46,"class":47},""]