[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Zelgen Biopharmaceuticals Co.,Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":444},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,41,64,82,102,122,141,159,177,196,213,231,249,270,289,310,331,351,368,388,406,425],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637564","phase-3-a-study-of-zg006-for-injection-versus-investigator-selected-chemotherapy-in-participants-with-advanced-neuroendocrine-carcinoma-100637564",false,"NCT07595913","A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma","A Phase III, Multicenter, Randomized, Open-Label, Controlled Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Has provided written informed consent voluntarily after being fully informed about the study.\n* Male or female, aged 18 to 75 years (inclusive) at the time of informed consent signing.\n* Histologically or cytologically confirmed advanced neuroendocrine carcinoma (NEC); small cell lung cancer (SCLC) and combined SCLC are excluded. Additionally, the Participants with DLL3-positive NEC who have received prior systemic therapy (second-line and above)..\n\nExclusion Criteria:\n\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This Phase III, multicenter, randomized, open-label, controlled study is designed to assess the efficacy and safety of ZG006 versus investigator-selected chemotherapy in participants with DLL3-positive advanced neuroendocrine carcinoma who have received prior systemic therapy.",[27],"Neuroendocrine Carcinoma","NOT_YET_RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-19","ACTUAL",{"date":34,"type":21},"2026-07",{"date":36,"type":21},"2028-12",{"name":38,"class":39},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":40},"100612787","phase-1-study-of-zggs34-in-participants-with-advanced-solid-tumors-100612787","NCT07258121","Study of ZGGS34 in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Dose Escalation and Cohort Expansion Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZGGS34 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years old.\n* Archived tumor tissue within 24 months or fresh biopsy specimens must be provided for detection of MUC17 expression, and with positive MUC17 results required.\n* Subjects in different study parts need to meet the following requirements:\n\nPart 1: Dose Escalation Study：Histologically or cytologically confirmed advanced solid tumors who have failed standard treatment or no standard treatment available, or were intolerant to standard treatments.\n\nPart 2: Cohort Expansion Study：Cohort 1 (Gastric cancer): Previously received at least one line systematic treatment and failed; HER2 status negative. Cohort 2 (Pancreatic cancer): Previously received at least one line systematic treatment and failed. Cohort 3 (Colorectal cancer): Previously received at least one line systematic treatment and failed; If patients with MSI-H\u002FdMMR, prior PD-1 therapy is required. Cohort 4: Other patients with advanced solid tumors who have failed standard treatment or have no standard treatment available.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments: Prior combination or sequential use of drugs targeting anti-MUC17 (including investigational drugs);Chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and biological targeted medicines ≤ 4 weeks before the first dose. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks before the first dose; Systemic immunosuppressive medications, such as corticosteroid within 14 days prior to the first dose; Use of any live or live attenuated vaccines against viral infections within 4 weeks of first dose.\n* The investigator considers the subject unsuitable for enrollment in this clinical study for any other reason.",{"count":49,"type":21},400,[51,52],"PHASE1","PHASE2","This is a multicenter, open-label Phase 1\u002F2 study in participants with advanced solid tumors. The study consists of two parts: Part 1 is a dose-escalation phase to evaluate the safety and tolerability of ZGGS34 in advanced solid tumor participants; Part 2 is a cohort-expansion phase to assess the efficacy and safety of ZGGS34 (± chemotherapy) in selected MUC17-positive advanced solid tumor participants.",[55],"Solid Tumor","RECRUITING","2026-04-27",{"date":59,"type":32},"2026-04-28",{"date":61,"type":32},"2025-12-31",{"date":36,"type":21},{"name":38,"class":39},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":40},"100610735","phase-1-study-of-zg006-in-combination-with-pd-1pd-l1-immune-checkpoint-inhibitors-as-first-line-standard-therapy-in-participants-with-extensive-stage-small-cell-lung-cancer-100610735","NCT07231445","Study of ZG006 in Combination With PD-1\u002FPD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer","A Phase Ib Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1\u002FPD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed ES-SCLC.\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":72,"type":21},100,[51],"This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1\u002FPD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.",[76],"Small Cell Lung Cancer",{"date":59,"type":32},{"date":79,"type":32},"2026-04-21",{"date":36,"type":21},{"name":38,"class":39},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":40},"100600596","phase-2-study-of-zg005-in-combination-with-platinum-based-chemotherapy-in-participants-with-advanced-biliary-tract-carcinoma-100600596","NCT07099547","Study of ZG005 in Combination With Platinum-Based Chemotherapy in Participants With Advanced Biliary Tract Carcinoma","A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Platinum-Based Chemotherapy as First-Line Treatment in Participants With Advanced Biliary Tract Carcinoma","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Subjects with a histopathological or cytologically diagnosis of Gallbladder cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":90,"type":21},60,[52],"This is a randomized, open-label, phase II study evaluating first-line treatment for advanced gallbladder cancer. It aims to assess the efficacy, safety, pharmacokinetics, and immunogenicity of the ZG005 in Combination with gemcitabine and cisplatin as first-line therapy in Participants with advanced gallbladder cancer.",[94],"Biliary Tract Carcinoma",{"date":96,"type":32},"2026-05-01",{"date":98,"type":32},"2025-12-02",{"date":100,"type":21},"2027-12",{"name":38,"class":39},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":121,"locationsCount":40},"100607507","phase-3-study-comparing-zg006-with-investigator-selected-chemotherapy-in-participants-with-relapsed-small-cell-lung-cancer-100607507","NCT07189455","Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer","A Multicenter, Randomized, Controlled, Open-Label Phase III Study Evaluating the Efficacy and Safety of ZG006 for Injection Compared With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Histologically or cytologically confirmed Small Cell Lung Cancer.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":110,"type":21},420,[24],"The main objective is to compare ZG006 with Investigator-Selected Chemotherapy on prolonging overall survival (OS).",[114],"Small-cell Lung Cancer","2025-12-30",{"date":117,"type":32},"2026-01-05",{"date":119,"type":32},"2025-12-12",{"date":36,"type":21},{"name":38,"class":39},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":129,"minAge":17,"maxAge":18,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":140,"locationsCount":40},"100599109","phase-1-study-of-zg005-in-combination-with-gecacitinib-in-participants-with-advanced-cervical-cancer-100599109","NCT07080216","Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","A Multicenter, Open-label, Dose-finding and Dose-expansion Phase I\u002FII Study of ZG005 in Combination With Gecacitinib in Participants With Advanced Cervical Cancer","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Female 18-75 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Histologically or cytologically confirmed advanced cervical cancer, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.\n\nExclusion Criteria:\n\n* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.","FEMALE",{"count":131,"type":21},120,[51,52],"This is a multicenter, open-label phase I\u002FII study in patients with advanced cervical cancer designed to evaluate the safety, tolerability, and preliminary efficacy of ZG005 in combination with Gecacitinib ± bevacizumab.",[135],"Cervical Cancer",{"date":117,"type":32},{"date":138,"type":32},"2025-09-23",{"date":100,"type":21},{"name":38,"class":39},{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":156,"leadSponsor":158,"locationsCount":40},"100595872","phase-1-zg006-and-zg005-in-participants-with-small-cell-lung-cancer-or-neuroendocrine-carcinoma-100595872","NCT07038096","ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","A Phase Ib\u002FII Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age.\n* Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.\n* Eastern Cooperative Oncology Group (ECOG) 0 to 1.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.","70 Years",{"count":150,"type":21},350,[51,52],"This study is a randomized, multicenter, Phase Ib\u002FII clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.",[76,27],{"date":117,"type":32},{"date":138,"type":32},{"date":157,"type":21},"2027-09",{"name":38,"class":39},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":40},"100588244","phase-1-study-of-zggs18-in-combination-with-zg005-in-patients-with-advanced-solid-tumors-100588244","NCT06938880","Study of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZGGS18 in Combination With ZG005 in Patients With Advanced Solid Tumors, Including Cervical Cancer, Hepatocellular Carcinoma, Neuroendocrine Tumors, and Lung Cancer","Inclusion Criteria:\n\n* Fully understand this study and voluntarily sign the ICF.\n* Age 18-75 years, no gender restriction.\n* Patients with advanced solid tumors who have failed standard treatment or are intolerant to standard treatment, as confirmed by histopathology or cytology.\n\nExclusion Criteria:\n\n* Medical history, CT scan, or MRI indicates the presence of CNS metastases.\n* Other malignancies within 5 years.\n* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.",{"count":90,"type":21},[51,52],"This trial is designed to assess the tolerability, safety, pharmacokinetic profile, and preliminary efficacy of the combination of ZGGS18 and ZG005 in patients with advanced solid tumors, including advanced cervical cancer, hepatocellular carcinoma, neuroendocrine cancer, and lung cancer.",[170],"Advanced Solid Tumor",{"date":117,"type":32},{"date":173,"type":32},"2025-05-20",{"date":175,"type":21},"2028-04",{"name":38,"class":39},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":40},"100585516","phase-1-study-of-zg005-combined-with-gecacitinib-in-patients-with-advanced-non-small-cell-lung-cancer-100585516","NCT06903377","Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer","A Multicenter, Open-label, Dose-Escalation and Dose-Expansion Phase I\u002FII Study of ZG005 Combined With Gecacitinib in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Fully understand this study and voluntarily sign the ICF.\n* Age 18-75 years, no gender restriction.\n* Patients with locally advanced or recurrent\u002Fmetastatic squamous and\u002For non-squamous non-small cell lung cancer confirmed by histology\u002Fcytology, unsuitable for radical therapy.\n\nExclusion Criteria:\n\n* Medical history, CT scan, or MRI indicates the presence of CNS metastases.\n* Other malignancies within 5 years.\n* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.",{"count":185,"type":21},50,[51,52],"This is a multicenter Phase I\u002FII study for patients with advanced non-small cell lung cancer who have failed PD-1\u002FL1 therapy, aiming to evaluate the safety of ZG005 in combination with Gecacitinib in this population, as well as the preliminary efficacy of this combination regimen.",[189],"Non-small Cell Lung Cancer",{"date":117,"type":32},{"date":192,"type":32},"2025-05-23",{"date":194,"type":21},"2027-05",{"name":38,"class":39},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":212,"locationsCount":40},"100583991","phase-1-study-of-zg005-in-combination-with-gecacitinib-in-patients-with-relapsed-or-refractory-lymphoma-100583991","NCT06883526","Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma","A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I\u002FII Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma","Inclusion Criteria:\n\n* Fully understand this study and voluntarily sign the ICF；\n* Age ≥18 at ICF signing, regardless of gender；\n* Histologically confirmed relapsed or refractory lymphoma.\n\nExclusion Criteria:\n\n* Lymphoma with known CNS involvement；\n* Severe cardiovascular\u002Fcerebrovascular diseases.\n* Any other reason deeming the participant unsuitable for the study, as judged by the investigator.",{"count":90,"type":21},[51,52],"PART 1:\n\n1. To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.\n2. To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.\n\nPART 2:\n\nTo evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.",[207],"Lymphoma",{"date":117,"type":32},{"date":210,"type":32},"2025-05-16",{"date":194,"type":21},{"name":38,"class":39},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":40},"100514422","phase-1-study-of-zg006-in-participants-with-small-cell-lung-cancer-or-neuroendocrine-carcinoma-100514422","NCT05978284","Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","A Phase 1\u002F2 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC), neuroendocrine carcinoma (NEC), who had no standard treatment available, or were intolerant to standard treatments;\n* Archival tissue sample or fresh biopsy tissue sample must be available for DLL3 detection;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Must have evaluable or measurable lesion. For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered evaluable or measurable lesions;\n* All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1, except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc.;\n* Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments:\n\nAnti-DLL3 and anti-CD3 drugs (including investigational drugs); Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry; Systemic immunosuppressive medications, such as corticosteroid (doses \\> 10 mg\u002Fday prednisone or equivalent dose) within 14 days prior to the study entry; Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;\n\n* Received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry.\n* The main organ function meets any of the following criteria within 7 days prior to study entry; Hematological function: ANC \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 75×10\\^9\u002FL, Hemoglobin (Hb) \\\u003C 100 g\u002FL; Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN, ALT and AST ≥ 5×ULN for liver metastases patients; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin \\\u003C 30g\u002FL; Creatinine clearance (Cockcroft-Gault formula) \\\u003C 50 mL\u002Fmin; INR \\> 1.5 or APTT \\> 1.5×ULN;\n* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate the existence of central nervous system (CNS) metastases; Note: Not applicable to the following conditions: subjects with stable CNS metastases;\n* Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;\n* Any other malignancy within 5 years (other than radically removed and has not recurred tumors including basal cell skin carcinoma, squamous cell skin carcinoma, superficial bladder cancer, localized prostate cancer, cervical cancer and other cancer in situ, etc.);\n* Severe cardiac-cerebral vascular disease, including but not limited to:\n\nAcute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before study entry; New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or the lower limit of normal; Uncontrollable hypertension (even though the best treatment is used but systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg).\n\nQTc (F) interval prolonged in electrocardiography during the screening baseline period (\\> 480 ms)\n\n* History of autoimmune disease, including but not limited to systemic lupus erythematosus, nephritis, psoriasis, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis (except for the following: type I diabetes mellitus, skin diseases that do not require systemic treatment (such as vitiligo), controllable celiac disease, and childhood asthma that completely resolved in adulthood without intervention);\n* Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, or active human immunodeficiency virus infection). Active hepatitis B is defined as: hepatitis B virus DNA titer \\> 10000 copies\u002FmL or 2000 IU\u002FmL; active hepatitis C is defined as: a positive hepatitis C antibody and HCV viral load above the limit of quantification; active human immunodeficiency virus infection is defined as: antibody positive;\n* Active neurologic paraneoplastic syndrome;\n* Interstitial lung disease or non-infectious pneumonitis (other than radiation-induced pneumonia);\n* Having received prior allogeneic stem cell transplantation or solid organ transplantation;\n* Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;\n* Known history of diagnosed neurological or mental disorders, for example, epilepsy, dementia, etc.;\n* A female who is pregnant or nursing;\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":221,"type":21},54,[51,52],"This is a multi-center, open-label, Phase Ⅰ\u002FⅡ clinical study of ZG006 for the treatment of participants with small cell lung cancer or neuroendocrine carcinoma who had no standard treatment available, or were intolerant to standard treatment.",[76,27],{"date":117,"type":32},{"date":227,"type":32},"2023-10-27",{"date":229,"type":21},"2026-10",{"name":38,"class":39},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":40},"100484189","phase-1-study-of-zggs18-in-patients-with-advanced-solid-tumors-100484189","NCT05584800","Study of ZGGS18 in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose Escalation, Tolerability, Safety, Pharmacokinetics and Multiple Cohort Expansion Study of ZGGS18 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.\n\nExclusion Criteria:\n\n* The investigator considers that any subjects are not suitable to participate in the trial.",{"count":239,"type":21},222,[51,52],"A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors",[170],{"date":117,"type":32},{"date":245,"type":32},"2022-11-15",{"date":247,"type":21},"2026-11-01",{"name":38,"class":39},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":40},"100537891","phase-1-dose-escalation-study-of-zg006-in-participants-with-advanced-small-cell-lung-cancer-or-neuroendocrine-carcinoma-followed-by-dose-expansion-study-in-participants-with-advanced-small-cell-lung-cancer-100537891","NCT06283719","Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer","A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months;\n* Participants with histologically or cytologically confirmed advanced solid tumors who also fulfill the following: Part 1: advanced small-cell lung cancer (SCLC) or neuroendocrine carcinoma.Part 2: advanced SCLC.Specifically for Part 2 Cohort 1: de-novo SCLC (composite SCLC excluded).Stage 2 restricted to third-line or later.Cohort 2: transformed SCLC.Cohort 3: large-cell neuroendocrine carcinoma of the lung and composite SCLC.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":257,"type":21},265,[51,52],"This is a multicenter, open-label Phase I\u002FII study consisting of two parts:\n\nPart 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data.\n\nPart 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.",[76,261],"Neuroendocrine Cancer","2025-11-13",{"date":264,"type":32},"2025-11-17",{"date":266,"type":32},"2024-09-02",{"date":268,"type":21},"2026-04",{"name":38,"class":39},{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":40},"100603924","phase-1-study-of-zg005-in-combination-with-gecacitinib-and-chemotherapy-for-participants-with-advanced-solid-tumors-100603924","NCT07142837","Study of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors","A Study to Evaluate the Efficacy and Safety of ZG005 in Combination With Gecacitinib and Chemotherapy for Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-75 years of age.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* PART 1: Histologically confirmed unresectable locally advanced, recurrent, or metastatic solid tumors.PART 2 Cohort A: Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Cohort B: Histologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma. Cohort C: Histologically confirmed unresectable locally advanced, recurrent, or metastatic other solid tumors.\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* participants were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":278,"type":21},153,[51,52],"This is a multicenter, open-label phase I\u002FII study for participants with advanced solid tumors who have failed prior immune checkpoint inhibitor therapies.",[170],"2025-08-25",{"date":284,"type":32},"2025-08-27",{"date":286,"type":21},"2025-09",{"date":100,"type":21},{"name":38,"class":39},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},"100561628","phase-1-a-phase-1-dose-escalation-study-of-zg006-in-patients-with-small-cell-lung-cancer-100561628","NCT06592638","A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer","A Phase 1 Dose Escalation Study of the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG006 in Patients With Small Cell Lung Cancer","Inclusion Criteria:\n\n* Small cell lung cancer (SCLC), who failed or intolerant to available standard treatments;\n* Tissue sample positive for DLL3 expression;\n* Life expectancy ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;\n* Female and Male patients must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* Patients having received any of the following treatments:\n\n  * Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines ≤ 4 weeks before the study entry. Local palliative radiotherapy and a small molecule targeted therapy ≤ 2 weeks (or 5 half-lives, whichever is longer) before the study entry;\n  * Systemic immunosuppressive medications, such as corticosteroid (doses \\> 10 mg\u002Fday prednisone or equivalent dose) within 14 days prior to the study entry;\n  * Use of any vaccines against viral infections (COVID-19, influenza, varicella, etc.) within 4 weeks of study entry;\n* Patients received any blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy within 14 days prior to study entry;\n* A history of severe, life-threatening immune-mediated adverse events or infusion-related reactions during previous anti-tumor immunotherapy, including events that led to permanent discontinuation of treatment;\n* Active infection (such as acute bacterial infection, tuberculosis, active hepatitis B\u002FC, active syphilis, or active human immunodeficiency virus infection);\n* Known allergy to other mAbs or any antibody excipients; the history of a severe allergic reaction, anaphylactoid or other hypersensitivity reactions to humanized antibodies or fusion proteins;\n* A female who is pregnant or nursing;\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":297,"type":21},30,[51],"This is a multi-center, open-label, Phase 1 clinical study of ZG006 in the US for the treatment of subjects with small cell lung cancer who have failed or are intolerant to available standard treatment. During the dose escalation stage, a standard \"3+3\" design will be used to assess the MTD\u002F recommended dose for the subsequent studies.",[76],"2025-07-31",{"date":303,"type":32},"2025-08-06",{"date":305,"type":32},"2025-03-31",{"date":307,"type":21},"2027-06",{"name":38,"class":39},6,{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":317,"minAge":17,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":330,"locationsCount":40},"100594809","phase-2-study-of-zg006-in-participants-with-neuroendocrine-prostate-cancer-100594809","NCT07024277","Study of ZG006 in Participants With Neuroendocrine Prostate Cancer","A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer","Inclusion Criteria:\n\n* Male Participants aged 18 to 80 years (inclusive);\n* Advanced metastatic neuroendocrine prostate cancer;\n* disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;\n* Measurable disease according to RECIST v1.1 criteria;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nExclusion Criteria:\n\n* Known positive test for human immunodeficiency virus (HIV) or hepatitis；\n* Patients were deemed unsuitable for participating in the study by the investigator for any reason.","MALE","80 Years",{"count":90,"type":21},[52],"This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.",[323],"Neuroendocrine Prostate Cancer","2025-06-09",{"date":326,"type":32},"2025-06-17",{"date":328,"type":21},"2025-08",{"date":100,"type":21},{"name":38,"class":39},{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":40},"100558984","phase-2-study-of-zg005-combined-with-bevacizumab-versus-sintilimab-combined-with-bevacizumab-in-advanced-hepatocellular-carcinoma-100558984","NCT06558227","Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma","A Multicenter, Randomized, Open-label Phase II Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab for First-line Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* 18-75 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1；\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":339,"type":21},90,[52],"This study is a randomized, open-label, positive-controlled, multicenter phase II clinical trial. It evaluates the efficacy and safety of ZG005 combined with Bevacizumab compared to Sintilimab combined with Bevacizumab in first-line treatment for patients with advanced hepatocellular carcinoma.",[343],"Hepatocellular Carcinoma","2024-12-11",{"date":346,"type":32},"2024-12-16",{"date":348,"type":32},"2024-10-24",{"date":229,"type":21},{"name":38,"class":39},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":40},"100549899","phase-1-dose-escalation-study-of-zg006-in-participants-with-advanced-small-cell-lung-cancer-or-neuroendocrine-carcinoma-followed-by-dose-expansion-study-in-participants-with-neuroendocrine-carcinoma-100549899","NCT06440057","Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form;\n* Male or female 18\\~75 years of age;\n* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Participants were deemed unsuitable for participating in the study by the investigator for any reason.",{"count":359,"type":21},78,[51,52],"This is a multicenter, open-label phase I\u002FII study, divided into 2 parts:\n\nPart 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.\n\nPart 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.",[27],{"date":346,"type":32},{"date":365,"type":32},"2024-08-29",{"date":34,"type":21},{"name":38,"class":39},{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":148,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":40},"100544725","phase-1-study-of-zg005-in-combination-with-etoposide-and-cisplatin-in-participants-with-advanced-neuroendocrine-carcinoma-100544725","NCT06372626","Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","A Phase I\u002FII Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n* Histologically confirmed recurrent or metastatic neuroendocrine carcinoma\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;\n* Any other malignancy within 5 years.\n* participants were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":376,"type":21},93,[51,52],"The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.",[27],"2024-06-13",{"date":382,"type":32},"2024-06-14",{"date":384,"type":32},"2024-05-30",{"date":386,"type":21},"2026-08",{"name":38,"class":39},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":148,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":40},"100534474","phase-1-a-study-of-zg005-combined-with-donafenib-in-patients-with-advanced-solid-tumor-100534474","NCT06239298","A Study of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor","A Multi-center, Open, Dose Exploration and Dose Expansion Phase I\u002FII Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or\n* Life expectancy ≥ 3 months.\n\nExclusion Criteria:\n\n* Patients were deemed unsuitable for participating in the study by the investigator for any reasons.",{"count":396,"type":21},130,[51,52],"This is a Multi-center, Open-labe, Phase I\u002FII Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.",[55],{"date":382,"type":32},{"date":402,"type":32},"2024-05-10",{"date":404,"type":21},"2026-05",{"name":38,"class":39},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":148,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":40},"100534012","phase-1-a-study-of-zg005-in-patients-with-advanced-solid-tumors-100534012","NCT06233292","A Study of ZG005 in Patients With Advanced Solid Tumors","A Phase 1\u002F2 Dose Escalation, Tolerability, Safety and Pharmacokinetics Study of ZG005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form.\n* Male or female 18-70 years of age;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;\n* Life expectancy ≥ 3 months;\n* Histologically or cytologically confirmed diagnosis of advanced solid tumors.\n\nExclusion Criteria:\n\n* Medical history, computed tomography (CT) or magnetic resonance imaging (MRI) results indicate that existence of the central nervous system(CNS) metastases;\n* Any other malignancy within 5 years.",{"count":414,"type":21},484,[51,52],"This is a multi-center, open-label, Phase 1\u002F2 study of ZG005 for the treatment of subjects with advanced solid tumors, and consists of three stages: dose escalation and confirmation of MTD\u002Frecommended dose.",[418],"Solid Tumors",{"date":382,"type":32},{"date":421,"type":32},"2022-06-17",{"date":423,"type":21},"2026-01",{"name":38,"class":39},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":40},"100506690","phase-1-study-of-zg0895hcl-in-patients-with-advanced-solid-tumors-100506690","NCT05877664","Study of ZG0895.HCl in Patients With Advanced Solid Tumors","A Phase 1 Dose Escalation and Expansion, Tolerability, Safety, Pharmacokinetics \u002F Pharmacodynamics and Preliminary Efficacy Study of ZG0895.HCl in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Fully understand the study and voluntarily sign the informed consent form(ICF).\n* Age ≥ 18 and ≤ 75 years old at the time of signing the ICF, either male or female;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy ≥ 3 months.\n* All adverse events from prior treatment have either returned to baseline or CTCAE 5.0 ≤ Grade 1(except for AEs not constituting a safety risk in the opinions of the investigators, e.g. alopecia, hypothyroidism which can be treated with a hormone replacement, etc).\n* Both male and female participants (unless postmenopausal, surgical sterilization) and partners must agree to use a reliable form of contraception during the study treatment period and for at least 6 months after the last dose of the study drug.\n* For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.\n\nPart 1:\n\n* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1).\n* Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors, in whom available standard treatments failed or were intolerable.\n\nExclusion Criteria:\n\n* Participants receiving any of the following treatments:\n\n  1. Previously treated with systemic TLR7\u002F8 immunomodulators.\n  2. Any other investigational product treatment within 4 weeks before the first dosing.\n  3. Chemotherapy, biotherapy, endocrine therapy (except for hormone replacement), and biological targeted medicines within 4 weeks before the first dosing. Local palliative radiotherapy, traditional Chinese medicine with anti-tumor effect, and small molecule targeted therapy within 2 weeks (or 5 half-lives, whichever is longer) before the first dosing.\n  4. Major surgery within 4 weeks before the first dosing for any reason (excluding puncture biopsy), or need to undergo elective surgery during the trial.\n  5. Potent CYP3A4\u002F5 inducer or inhibitor within 2 weeks prior to administration of the first dose of the study drug.\n  6. Systemic immunosuppressive drugs within 2 weeks prior to administration of the first dose of the study drug, including systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent).\n  7. Other immunomodulators within 2 weeks prior to administration of the first dose of the study drug, including but not limited to thymosin, interleukin-2 and interferon.\n* Had CTCAE Grade ≥3 immune-related adverse events (irAE) after receiving immunotherapy.\n* The main organ function meets any of the following criteria within 7 days prior to the first dosing. （Note: blood transfusion, EPO, G-CSF, albumin infusion and renal replacement therapy are not allowed within 14 days prior to treatment.)\n\n  1. Hematological function: ANC \\\u003C 1.5×10\\^9\u002FL, PLT \\\u003C 75×10\\^9\u002FL, Hemoglobin (Hb) \\\u003C 100 g\u002FL.\n  2. Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3×ULN; ALT and AST ≥ 5×ULN for participants with liver metastases; Total bilirubin (TBIL) ≥ 1.5×ULN; albumin \\\u003C 30 g\u002FL.\n  3. Creatinine clearance\\\u003C 75 mL\u002Fmin.\n  4. INR \\> 1.5 or APTT \\> 1.5×ULN.\n  5. The urine protein presents positive and the quantitative result of 24-h urine protein ≥ 1 g.\n* Participants with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis; or other evidence suggesting that the central nervous system metastasis or meningeal metastasis is not well-controlled and is judged by the investigator to be unsuitable for enrollment.\n* Uncontrollable third cavity effusion (e.g. large amount pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which is judged by the investigator to be unsuitable for enrollment.\n* Known history of neurological disorders affecting brain functional activities, including epilepsy or dementia.\n* Severe cardiac-cerebral vascular disease, including but not limited to:\n\n  1. Acute myocardial infarction, unstable angina, stroke, or received coronary angioplasty or stent implantation within 6 months before the first dosing.\n  2. New York Heart Association functional class II to IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or the lower normal limit.\n  3. Uncontrollable hypertension (even though the best available treatment is used but systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n  4. QTcF interval prolongation during the baseline period.\n* Participants with active or history of autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases.\n* Active infection requiring systemic therapy within 7 days prior to the first dosing; active hepatitis B or hepatitis C, history of immunodeficiency virus (HIV) disease or HIV antibody positive.\n* Priorly received allogeneic stem cell transplantation or solid organ transplantation.\n* Known allergy to the ZG0895.HCl or any of its excipients; have severe allergy history (CTCAE Grade ≥ 3), such as severe urticaria, angioedema, severe anaphylaxis, etc.\n* Females who are pregnant or nursing during the screening period.\n* The investigators consider that the participants are not suitable to participate in the clinical study for other reasons.",{"count":90,"type":21},[51],"The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)\u002F recommended phase 2 dose (RP2D) of ZG0895.HCl.",[170],"2024-03-04",{"date":438,"type":32},"2024-03-06",{"date":440,"type":32},"2023-08-08",{"date":442,"type":21},"2026-06",{"name":38,"class":39},""]