[{"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:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,65],{"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","2026-04-13",{"date":32,"type":33},"2026-04-14","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":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"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":51,"type":21},156,[24],"This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced\u002Fmetastatic Solid Tumors",[55],"Advanced\u002FMetastatic Solid Tumors","2026-04-10",{"date":58,"type":33},"2026-04-15",{"date":60,"type":33},"2023-03-27",{"date":62,"type":21},"2027-12-30",{"name":39,"class":40},22,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100518271","phase-1-a-study-of-atg-031-in-advanced-solid-tumors-or-b-cell-non-hodgkin-lymphomas-100518271","NCT06028373","A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas","A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas","Key Inclusion Criteria:\n\n1. Histological or cytologically confirmed advanced solid tumor or B-NHL which have relapsed from or been refractory to all locally available standard therapies.\n2. Adequate hepatic function:\n\n   1. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).\n   2. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).\n   3. Lipase and amylase ≤ 2×ULN.\n3. Adequate renal function: calculated creatinine clearance of ≥ 40 mL\u002Fmin using the Cockroft- Gault formula.\n4. Adequate bone marrow function without growth factors or blood transfusion within 7 days of the first dose of study treatment.\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL.\n   2. Platelet count ≥ 100×109\u002FL.\n   3. Hemoglobin ≥ 90 g\u002FL.\n\nKey Exclusion Criteria:\n\n1. Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks and off corticosteroids following prior surgery, whole-brain radiation, or stereotactic radiosurgery.\n2. Received any other investigational product or prior systemic anticancer therapy including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21 days prior to first dose of study\n3. Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other primary malignancies developed within 5 years prior to the first dose of the study treatment\n4. Other primary malignancies developed within 5 years prior to the first dose of the study treatment\n5. Have active or previous autoimmune diseases that are likely to recur or are at risk of such diseases judged by the investigator.\n6. Major cardiovascular disease\n7. Active hepatitis B and\u002For hepatitis C (HBV-DNA or HCV-RNA detectable by local laboratory, respectively).\n8. Patients with history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n9. A history of allograft organ transplantation for solid tumor or allogeneic hematopoietic stem cell transplantation for B-NHL patients).\n10. Patients who are pregnant or lactating.",{"count":73,"type":21},80,[24],"ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e., preferred tumor types) or relapsed\u002Frefractory (R\u002FR) B-NHLs. The study's primary objective is to evaluate the safety and tolerability of ATG-031 and determine the RP2D（Refered Phase II dose） of ATG-031.",[77,78],"Advanced Solid Tumors","B-cell Non-Hodgkin Lymphomas",[80,81,82],"ATG-031","solid tumor","CD 24","2025-06-05",{"date":85,"type":33},"2025-06-09",{"date":87,"type":33},"2023-12-08",{"date":89,"type":21},"2027-06-30",{"name":39,"class":40},4,""]