[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Antengene Biologics Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100618100","phase-1-a-phase-ibii-study-of-atg-022-plus-pembrolizumab-withwithout-chemotherapy-in-participants-with-claudin-cldn-182-positive-her2-negative-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinomaunresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100618100",false,"NCT07327229","A Phase Ib\u002FII Study of ATG-022 Plus Pembrolizumab With\u002FWithout Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase Ib\u002FII Study of ATG-022 Plus Pembrolizumab With\u002FWithout Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","CLINCH-2","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.\n2. Aged ≥18 years as of the date of consent.\n3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression.\n4. Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria.\n5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators.\n6. Estimated life expectancy of a minimum of 12 weeks.\n\nExclusion Criteria:\n\n1. Known active central nervous system metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n2. Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE.\n3. Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator.\n4. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n5. Prior radiotherapy within 4 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. Two weeks or fewer of palliative radiotherapy for non- central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention\n6. Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n7. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures≤7 days. No waiting is required following implantable port and catheter placement.","ALL","18 Years",{"count":20,"type":21},132,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is A Phase Ib\u002FII Study of ATG-022 Plus Pembrolizumab With\u002FWithout Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma",[28],"Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","RECRUITING","2026-07-28",{"date":32,"type":33},"2026-07-29","ACTUAL",{"date":35,"type":33},"2026-02-27",{"date":37,"type":21},"2029-04-30",{"name":39,"class":40},"Antengene Biologics Limited","INDUSTRY",30,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100649228","phase-1-a-study-of-atg-201-in-adult-participants-with-autoimmune-diseases-100649228","NCT07732309","A Study of ATG-201 in Adult Participants With Autoimmune Diseases","A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases","ATTRACT","Inclusion Criteria:\n\n1. Participants who give consent to this study participation and sign informed consent form.\n2. Participants at least 18 years of age inclusive at screening visit.\n3. Must be able to adhere to the study visit schedule and other protocol .requirements.\n4. Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.\n5. Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.\n\nSLE: subjects:\n\n1. Have a confirmed diagnosis of SLE and meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria at screening.\n2. Have active SLE disease.\n3. Have had previous treatment failure.\n\nExclusion Criteria:\n\n1. Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).\n2. Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.\n3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.\n4. Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.\n5. Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.\n6. History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell\u002Fmarrow transplant.\n7. Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.\n8. Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\\>60 mg\u002Fday) within 2 months prior to screening.\n9. Live or attenuated vaccine within 28 days prior to screening or during screening.\n10. Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.\n11. The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.",{"count":51,"type":21},149,[24],"This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.",[55,56,57],"Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Sjogren's Disease","NOT_YET_RECRUITING","2026-07-24",{"date":30,"type":33},{"date":62,"type":21},"2026-09-01",{"date":64,"type":21},"2029-06-01",{"name":39,"class":40},22,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":66},"100494493","phase-1-a-study-of-atg-022-in-patients-with-advancedmetastatic-solid-tumors-100494493","NCT05718895","A Study of ATG-022 in Patients With Advanced\u002FMetastatic Solid Tumors","An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced\u002FMetastatic Solid Tumors","CLINCH","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.\n2. Aged at least 18 years as of the date of consent.\n3. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies).\n\n   1. Dose Escalation Phase: all solid tumors.\n   2. Dose Expansion Phase: Claudin 18.2 positive solid tumors.\n4. Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided.\n5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.\n6. Estimated life expectancy of a minimum of 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .\n8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening\n9. Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Primary central nervous system disease or central nervous system metastatic disease.\n2. Prior exposure to a Claudin 18.2 targeting agent.\n3. Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (eg, a period of 5 'half-lives'.\n4. Prior vaccination within 28 days of the first dose of study therapy.\n5. Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion \\\u003C 6 months prior to the first dose of study treatment.\n6. Active infection including hepatitis B, and\u002For hepatitis C.\n7. Known history of human immunodeficiency virus (HIV) infection.\n8. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.\n9. Pregnant or nursing females.\n10. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.\n11. Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .\n12. In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.",{"count":76,"type":21},156,[24],"This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced\u002Fmetastatic Solid Tumors",[80],"Advanced\u002FMetastatic Solid Tumors","2026-04-10",{"date":83,"type":33},"2026-04-15",{"date":85,"type":33},"2023-03-27",{"date":87,"type":21},"2027-12-30",{"name":39,"class":40},""]