[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Escugen Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100621815","phase-2-a-phase-2-study-on-the-safety-and-efficacy-of-the-anti-baff-r-monoclonal-antibody-esg206-in-patients-with-primary-sjogren-syndrome-100621815",false,"NCT07375524","A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren Syndrome","Inclusion Criteria:\n\n* Adults (≥18 years of age) with a confirmed diagnosis of primary Sjögren's syndrome according to the 2016 American College of Rheumatology (ACR) \u002F European League Against Rheumatism (EULAR) classification criteria.\n* Evidence of active disease at screening\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Secondary Sjögren's syndrome or other clinically significant autoimmune or inflammatory diseases\n* Prior or recent use of prohibited immunomodulatory therapies\n* Clinically significant infections, malignancies, or uncontrolled medical conditions\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled Phase II study designed to evaluate the efficacy and safety of ESG206 in participants with primary Sjögren's syndrome.",[25],"Primary Sjögren Syndrome","NOT_YET_RECRUITING","2026-01-30",{"date":29,"type":30},"2026-02-03","ACTUAL",{"date":32,"type":19},"2026-03-01",{"date":34,"type":19},"2028-06-30",{"name":36,"class":37},"Shanghai Escugen Biotechnology Co., Ltd","INDUSTRY",21,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":20,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100591380","phase-1-study-of-esg406-in-adults-with-solid-tumors-100591380","NCT06979674","Study of ESG406 in Adults With Solid Tumors","An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","Key Inclusion Criteria:\n\n* Males and females aged 18 to 80 years.\n* Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.\n* At least one measurable lesion per RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥12 weeks.\n* Adequate organ and bone marrow function.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause.\n\nKey Exclusion Criteria:\n\n* Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.\n* Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.\n* Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.\n* Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.\n* A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.\n* History of (noninfectious) interstitial pneumonia (ILD)\u002Fnoninfectious pneumonitis requiring steroid therapy and current ILD\u002Fnoninfectious pneumonitis, or suspected ILD\u002Fnoninfectious pneumonitis at screening.\n* Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.\n* Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.\n* Patients with uncontrollable systemic diseases.\n* Subjects with clinically significant cardiovascular disease.\n* Human Immunodeficiency Virus (HIV) infection.\n* Active hepatitis B or hepatitis C.\n* Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient.\n* Pregnant or lactating women.","80 Years",{"count":48,"type":19},556,[50],"PHASE1","This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.",[53],"Locally Advanced\u002FMetastatic Solid Tumors","RECRUITING","2025-09-08",{"date":57,"type":30},"2025-09-12",{"date":59,"type":30},"2025-06-04",{"date":61,"type":19},"2028-06",{"name":36,"class":37},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":20,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100581679","phase-1-a-phase-12-study-of-esg206-in-patients-with-primary-immune-thrombocytopenia-100581679","NCT06853444","A Phase 1\u002F2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia","A Phase 1\u002F2 Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Immune Thrombocytopenia (ITP)","Inclusion Criteria:\n\n* 1\\. Willing and able to provide written informed consent for this trial.\n* 2\\. Male or female, age ≥ 18 years on the day of signing the informed consent form.\n* 3\\. Diagnosed with primary immune thrombocytopenia (ITP), and having received treatment of corticosteroids ± intravenous immunoglobulin (IVIG) in the past.\n* 4\\. At the time of the last ITP treatment, loss of response, insufficient response, no response or intolerance occurred.\n* 5\\. At screening, Platelet Count revealed \\\u003C 30 \\* 10\\^9\u002FL twice (with an interval of at least 24 hours between the two tests).\n* 6\\. Subjects must have adequate organ function.\n* 7\\. The World Health Organization (WHO) bleeding scale is 0-1.\n* 8\\. Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the informed consent until 180 days after the last dose of the trial drug. Women of reproductive age include premenopausal women and women within 2 years after menopause. Women who are fertile must have a pregnancy test within 7 days before the trial drug is first given and the result should be negative.\n\nExclusion Criteria:\n\n* 1\\. Diagnosed with secondary immune thrombocytopenia, or there is evidence that the patient has a secondary cause of immune thrombocytopenia, or the patient has multiple immune cytopenias.\n* 2\\. Previously received B-cell depletion therapy (e.g., rituximab, Ianalumab, etc.).\n* 3\\. Received platelet transfusion or whole blood transfusion, plasma exchange, or any other rescue treatment within 14 days before the first administration of the trial drug.\n* 4\\. Participated in other investigational drug clinical studies within 4 weeks before the first administration of the investigational drug or within 5 half-lives of the investigational drug received (whichever is longer).\n* 5\\. Underwent splenectomy within 12 weeks before the first administration of the investigational drug.\n* 6\\. Received traditional Chinese medicine treatment with definite platelet-raising effects within 1 week before the first administration of the trial drug.\n* 7\\. Underwent major surgery within 4 weeks before the first administration of the investigational drug or needs to undergo major elective surgery during the study period.\n* 8\\. Diagnosed with Evans syndrome or any other cytopenia (patients with mild anemia related to bleeding or iron deficiency are eligible for inclusion in the study).\n* 9\\. Patients with current or previous life-threatening bleeding related to thrombocytopenia.\n* 10\\. Patients with concurrent coagulation disorders and\u002For receiving antiplatelet or anticoagulant therapy (e.g., warfarin, clopidogrel, or new oral anticoagulants), except for low-dose acetylsalicylate (≤150 mg\u002Fday).\n* 11\\. Patients with deep vein thrombosis or arterial thrombosis within 6 months before enrollment, and\u002For with risk factors for hereditary thrombophilia.\n* 12\\. Patients with a history of severe cardiovascular and pulmonary diseases.\n* 13\\. Patients with uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n* 14\\. Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or liver cirrhosis.\n* 15\\. Patients with active viral, bacterial, or other infections requiring systemic treatment during the screening period, or with a history of clinically significant recurrent infections (e.g., bacterial infection with capsule). Patients with a history of tuberculosis (TB) or latent TB who have undergone anti-TB treatment may be eligible for inclusion.\n* 16\\. Patients who received live or attenuated live vaccines within 4 weeks before the first administration of the investigational drug.\n* 17\\. Patients with a history of or current malignant tumors, except for cured non-melanoma skin cancer, carcinoma in situ (e.g., cervical cancer, breast cancer, bladder cancer, prostate cancer), and cancers that have been in complete remission for at least 3 years without evidence of recurrence.\n* 18\\. Patients with any severe and\u002For unstable pre-existing medical, mental, or other conditions that the investigator deems may interfere with the patient's efficacy, safety, informed consent, or compliance with the study procedures.\n* 19\\. Patients with known immediate or delayed hypersensitivity reactions to monoclonal antibodies or components of the trial drug, or with a history of allergic constitution.\n* 20\\. Pregnant or lactating women.\n* 21\\. Patients who are unwilling or unable to follow the protocol procedures.",{"count":71,"type":19},84,[50,22],"This is a multicenter, open-label Phase1\u002F2 study aimed at evaluating the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ESG206. The study will be conducted in patients with primary immune thrombocytopenia.",[75],"Immune Thrombocytopenia (ITP)","2025-05-13",{"date":78,"type":30},"2025-05-16",{"date":80,"type":30},"2025-05-08",{"date":82,"type":19},"2027-04-30",{"name":36,"class":37},1,""]