[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shine-On Biomedical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100609850","phase-1-a-study-to-investigate-hla-g-targeted-exosome-sob100-in-healthy-subjects-100609850",false,"NCT07219940","A Study to Investigate HLA-G Targeted Exosome (SOB100) in Healthy Subjects","An Open-label and Dose-escalation Phase I Clinical Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of HLA-G-targeted Exosome (SOB100) in Healthy Subjects","αHLA-G Exo-01","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old\n2. Overtly healthy subject, who is considered to be generally healthy based on medical history, 12-lead ECG, and physical examinations, as judged by the Investigator\n3. Able to understand and comply with procedures in the protocol as judged by Investigator and sign the informed consent form (ICF)\n4. Adequate organ function\n\nExclusion Criteria:\n\n1. With known or suspected to be hypersensitivity to HLA-G related treatment.\n2. Confirmed active HIV, HBV, or HCV infection\n3. With active fungal, bacterial, viral or atypical infection requiring systemic medication\n4. History of cancer (malignancy) or have ever received any anti-cancer therapy\n5. Has ever received cell therapy or organ transplantation\n6. Substance abuse or addictive use of drugs for nonmedical purposes\n7. Female subject is lactating, has a positive pregnancy test or refuse to practice highly effective contraception\n8. Male subjects with a female spouse\u002Fpartner who is of childbearing potential refuse to adopt at least one highly effective method of contraception",true,"ALL","18 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The investigational drug, SOB100, is an HLA-G targeted exosome equipped with a nanobody namely anti-HLA-G VHH on the exosome membrane. This is a Phase I dose escalation study to exam the tolerability, safety, and pharmacokinetics in healthy subjects.",[28,29,30],"Healthy Subjects","Exosome","Targeted Therapy","RECRUITING","2026-01-22",{"date":34,"type":35},"2026-01-26","ACTUAL",{"date":37,"type":35},"2025-12-01",{"date":39,"type":22},"2027-03",{"name":41,"class":42},"Shine-On Biomedical Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100597215","phase-1-a-study-to-investigate-safety-and-preliminary-efficacy-of-soa101-in-adult-subjects-with-advanced-solid-tumors-100597215","NCT07055594","A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors","A Phase I\u002FIIa Dose-escalation, Dose-optimization and Dose Expansion Study to Evaluate the Safety and Preliminary Efficacy of Tri-specific Antibody (SOA101) in Subjects With Advanced Solid Tumors.","NbTAST-01","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, or metastatic solid tumors confirmed histologically or cytologically as one of the following cancer types for whom no suitable alternative standard-of-care therapy exists:\n\n   1. Non-small cell lung cancer (NSCLC);\n   2. Ovarian cancer (OC);\n   3. Head and neck carcinoma (H\\&N);\n   4. Breast cancer (BC);\n   5. Colorectal cancer (CRC).\n3. Pathologically confirmed combined positive score (CPS) with ≥ 1% expression of PD-L1.\n4. At least one measurable lesion\n5. Adequate organ function\n6. Female subject must either not be of childbearing potential or a negative pregnancy test\n7. Non-vasectomized male subjects must practice highly effective contraception\n\nExclusion Criteria:\n\n1. Active bacterial, fungal, viral OR atypical infection requiring systemic medication.\n2. Received any investigational drug within 4 weeks before screening.\n3. Confirmed active HIV (without controlled disease on HAART), HBV, or HCV infection.\n4. Symptomatic, unstable central nervous system malignancy OR metastasis\n5. Have received organ or tissue transplantation or allogeneic cell therapies.\n6. Non-adequate cardiac function\n7. Known hypersensitivity to any anti-PD-L1 therapy or anti-CD3 therapy.",{"count":53,"type":22},76,[25,55],"PHASE2","The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1\u002FHLA-G\u002FCD3. This is a Phase I\u002FIIa study including dose-escalation, dose optimization and dose expansion parts to exam safety, tolerability, pharmacokinetics, immunogenecity and efficacy of SOA101 on advanced or metastatic solid tumor treatment.",[58],"Solid Tumors","2025-11-04",{"date":61,"type":35},"2025-11-06",{"date":63,"type":35},"2025-07-30",{"date":65,"type":22},"2028-12",{"name":41,"class":42},""]