[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HitGen Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100576151","phase-2-clinical-trial-of-hg146-administered-to-participants-with-adenoid-cystic-carcinoma-100576151",false,"NCT06781567","Clinical Trial of HG146 Administered to Participants with Adenoid Cystic Carcinoma","A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants with Recurrent or Metastatic Adenoid Cystic Carcinoma.","HG146","Inclusion Criteria:\n\n* Signed informed consent form (ICF) and able to comply with study.\n* Age ≥18 years, gender unlimited.\n* Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.\n* Estimated survival \\>12 weeks, as determined by the investigator.\n* The United States Eastern Cancer Consortium (ECOG) physical status score 0-1.\n* Has adequate organ function.\n* At least 1 measurable tumor lesion according to RECISTv1.1 criteria.\n\nExclusion Criteria:\n\n* Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.\n* Received prior therapies targeting HDAC.\n* Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment \\[small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.\n* Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.\n* Major surgery or major injury \\\u003C=28 days before the first dose of study treatment,or anticipated major surgery during the study.\n* Prior allogeneic bone marrow transplantation or other solid organ transplantation\n* Active infection requiring systemic treatment.\n* Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years.\n* A person is known to be allergic to any active ingredient or excipient of the investigational drug.\n* Pregnant or lactating women.\n* patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.","ALL","18 Years",{"count":20,"type":21},140,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.",[27,28],"Adenoid Cystic Carcinoma","Head and Neck Cancer",[15,30],"HG146CN201","RECRUITING","2025-03-11",{"date":34,"type":35},"2025-03-14","ACTUAL",{"date":37,"type":35},"2024-12-13",{"date":39,"type":21},"2029-06-30",{"name":41,"class":42},"HitGen Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100439140","phase-1-a-study-of-hg381-administered-to-patients-with-advanced-solid-tumors-100439140","NCT04998422","A Study of HG381 Administered to Patients With Advanced Solid Tumors","Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of HG381 as Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Life expectancy of at least 3 months.\n* Histological or cytological documentation of an advanced solid tumor，subjects with advanced\u002Frecurrent solid tumors, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.\n* Measurable disease per RECIST version 1.1, there is at least one measurable lesion during the screening period.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n* Adequate organ function : Hematologic system: Hemoglobin ≥9 g\u002FdL, Absolute neutrophil count \\[ANC\\] ≥1.5x10\\^9\u002FL, Platelets ≥100x10\\^9\u002FL, INR ≤ 1.5 and APTT ≤1.5 x ULN; Hepatic system: Total bilirubin ≤1.5 x ULN, ALT and AST ≤ 2.5 x ULN; Renal system: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); Cardiac system: left ventricular ejection fraction (LVEF) ≥50% ; QT interval (QTcF) ≤470 ms for women, and ≤450 ms for men; Endocrine system: Thyroid-stimulating hormone (TSH) is within the normal limits.\n* Subjects with fertility must agree to take medically approved effective contraceptive measures during the entire trial period and at least 3 months after the last medication.\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anticancer therapy within 4 weeks.\n* Concurrent medical condition requiring the use of other systemic immunosuppressive treatment within 4 weeks before the first dose of study treatment.\n* Receipt of any live vaccine within 4 weeks of the start of study treatment.\n* Receipt of unmarketed clinical trial drugs or treatments within 4 weeks of the start of study treatment.\n* Receipt of surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) within 4 weeks of the start of study treatment.\n* History or evidence of cardiovascular and cerebrovascular diseases risk.\n* Subjects with uncontrolled diabetes.\n* Symptomatic central nervous system (CNS) metastases or asymptomatic CNS metastases that have required steroids within 2 weeks prior to first dose of study treatment.\n* Currently or in the past suffering from malignant tumors.\n* Uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently after appropriate intervention.\n* Active or suspected autoimmune disease.\n* History of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia, or evidence of active, non-infectious pneumonitis.\n* Toxicity from previous treatment including: Toxicity Grade ≥3 related to prior immunotherapy and that led to study treatment discontinuation; Toxicity related to prior treatment that has not resolved to Grade ≤ 1.\n* Subjects who have acute bacterial, viral or fungal infections and require systemic anti-infective treatment.\n* Positive test for syphilis antibodies or human immunodeficiency virus (HIV) antibodies.\n* Subjects who are allergic to test drugs and excipients.\n* Women who are pregnant or breastfeeding.\n* Known drug or alcohol abuse.\n* Patients with mental or neurological diseases.\n* Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.\n* Subjects who have a history of serious systemic disease or any other reason are not suitable to participate in this trial as judged by the investigator.",{"count":52,"type":21},57,[54],"PHASE1","This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.",[57],"Advanced Solid Tumor",{"date":59,"type":35},"2025-03-13",{"date":61,"type":35},"2021-10-18",{"date":63,"type":21},"2025-12",{"name":41,"class":42},""]