[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen TargetRx Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,66,89,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100630598","phase-3-tgrx-678-chinese-phase-iii-in-chronic-myelogenous-leukemia-cml-patients-100630598",false,"NCT07489755","TGRX-678 Chinese Phase III in Chronic Myelogenous Leukemia (CML) Patients","A Randomized, Open-label, Multi-center Phase III Study Evaluating Efficacy and Safety of TGRX-678 Comparing to Investigator Selected Tyrosine Kinase Inhibitor (TKI) in CML-CP Patients Resistant From or Intolerant to at Least 3 TKI Treatments","Inclusion Criteria:\n\n* Willing to consent and to follow study procedures\n* 18 years of age or above at time of screening; both sexes eligible\n* Diagnosed with CML-CP and was intolerant to or failed from at least 3 TKI treatments\n* ECOG score \\>= 2\n* Adequate hematological indicators and have not used blood products or Colony-Stimulating Factor (CSF)\n* Adequate kidney, liver and coagulation function\n* Adequate QTc interval as confirmed by electrocardiogram (ECG) test\n* Negative pregnancy result at screening for female patients of child-bearing potential\n* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)\n\nExclusion Criteria:\n\n* Reception of TKI treatment or other anti-tumor treatments prior to first dose\n* History or presence of extramedullary leukemia\n* History of progression to CML-AP or BP\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of severe hemorrhagic disease\n* Presence of malabsorption or other conditions that may affect drug absorption\n* History of other primary malignancy within 5 years\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* In need for or having long-term immune suppressive treatment\n* Reception of major surgery 28 days before first dose\n* Presence of unrecovered toxicity due to anti-tumor treatment with CTCAE grade \\>=1\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","A Phase III study evaluating the safety and efficacy of TGRX-678 in CML-CP patients resistant from or intolerant to at least 3 TKIs",[26,27],"Chronic Myelogenous Leukemia","Chronic Myelogenous Leukemia - Chronic Phase","NOT_YET_RECRUITING","2026-03-18",{"date":31,"type":32},"2026-03-24","ACTUAL",{"date":34,"type":20},"2026-04-01",{"date":36,"type":20},"2031-05-01",{"name":38,"class":39},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100553340","phase-1-tgrx-1942-chinese-phase-i-for-advanced-solid-tumor-andor-relapsedrefractory-hematologic-malignancies-100553340","NCT06484816","TGRX-1942 Chinese Phase I for Advanced Solid Tumor And\u002For Relapsed\u002FRefractory Hematologic Malignancies","A Dose Escalation and Expansion Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-1942 in Patients with Advanced Solid Tumor And\u002For Relapsed\u002FRefractory Hematologic Malignancies","Inclusion Criteria:\n\n* For dose escalation phase, patient is diagnosed with advanced\u002Fmetastatic solid tumor who had failed standard therapies and does not have available effective treatment, or who relapsed from prior treatments\n* ECOG score of equals to or lower than 1\n* Life expectancy of at least 3 months\n* Adequate systemic and organ functions, including hematologic, hepatic and kidney functions\n* Willing to provide available tumor biopsy sample or reports, or willing to undergo tumor biopsy examination, and willing to partake whole blood sampling for evaluations\n* For female of child-bearing potential, willing to undergo plasma pregnancy test 28 days before first dose and have negative results\n* Male and Female of child-bearing potential must agree to take effective contraceptive measures during the entire treatment period and for 2 months after the end of treatment\n* Understand and willing to sign informed concent; willing and able to complete the visiting schedule and other tasks as required for the study\n\nExclusion Criteria:\n\n* Allergic to any of the ingredient of the investigational drug\n* History of other primary malignancies\n* Have adverse\u002Ftoxic effects from previous treatment that has not recovered to CTCAE 5.0 \\\u003C= Grade 1\n* Received other anti-tumor treatments (i.e., chemotherapy, biologics, immunotherapy, targeted therapy, etc.) 28 days before first dose, or radiation therapy 14 days before first dose\n* Used drugs known to significantly affect P450 metabolism 2 weeks before first dose\n* Participated in other clinical trials and used other investigational agents 28 days before first dose\n* Received major surgeries or had traumatic injuries 28 days before first dose\n* Need to use concomitant drugs that could cause QTc elongation or induce Torsades de Pointes\n* History or presence of other medical conditions, such as HIV\u002FHBV\u002FHCV positive; received anticoagulation treatment; coagulation dysfunction; major or clinically significant cardiovascular disease; pneumonia; clinically significant gastrointestinal abnormalities that could affect drug absorption; uncontrollable hypertension; ulcer in abdomen, intestine, stomach, trachea or esophagus; uncontrolled seizure or have other central nervous system diseases, poorly managed diabetes; long QT syndrome; uncontrolled active infections; uncontrolled pericardial or abdominal effusion; adrenaline malfunction; thyroid dysfunction; severe unhealed wound, ulcer or bone fractures; Toxic epidermal necrolysis; Stevens-Johnson syndrome\n* Have symptomatic or uncontrolled primary or metastatic central nervous system tumor or Leptomeninges tumor, or untreated diseases that cause compressions to spinal cords\n* For female patients: in pregnancy or breast-feeding periods\n* Presence of any condition or history that could affect study results or participation to the study in the judgement of the investigator\n* Used immunosuppressant drugs within14 days before first dose\n* Received vaccine injection within 30 days of Cycle 1 Day 1",{"count":48,"type":20},90,[50],"PHASE1","A phase I study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TGRX-1942 in patients with advanced solid tumor and\u002For relapsed or refractory hematological malignancies",[53,54,55],"Non Small Cell Lung Cancer","Advanced Solid Tumor","Hematologic Malignancy","RECRUITING","2025-02-20",{"date":59,"type":32},"2025-02-24",{"date":61,"type":32},"2024-07-08",{"date":63,"type":20},"2027-06",{"name":38,"class":39},1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":65},"100550962","phase-2-tgrx-678-chinese-phase-ii-in-chronic-myelogenous-leukemia-cml-patients-100550962","NCT06453902","TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients","A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment","Inclusion Criteria:\n\n* Willing to consent\n* 18 years of age or above at time of screening; both sexes eligible\n* Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment\n* For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI\n* For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment\n* Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests\n* ECOG score \\\u003C\u002F=2\n* Minimum life expectancy of at least 3 months\n* Adequate hematological indicators\n* Adequate kidney function\n* Adequate liver function\n* Adequate coagulation function\n* Adequate pancreatic function\n* Adequate QTc interval as confirmed by electrocardiogram (ECG) test\n* Negative pregnancy result at screening for female patients of child-bearing potential\n* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)\n\nExclusion Criteria:\n\n* Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose\n* Reception of other anti-tumor treatments\n* In need for immune suppressive treatment\n* Usage of drugs associated with Torsades de Pointes within 1 months before screening\n* Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug\n* History of hemapoietic stem cell transplant\n* Presence of active central nervous system conditions\n* CML-AP patients who already reached major hematological response\n* CML-AP patients who used to progress to Blast Phase (BP)\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160\u002F100 mmHg for 1 months before screening)\n* Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose\n* Severe hemorrhagic disease unrelated to CML\n* History of severe cardiovascular condition during past TKI treatment for CML\n* History of pancreatic inflammation or alcohol abuse within 3 years before first dose\n* Uncontrolled Hypertriglyceridemia\n* Presence of malabsorption or other conditions that may affect drug absorption\n* Diagnosis of other primary malignant tumor within 5 years\n* Reception of major surgery 14 days before first dose\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study",{"count":74,"type":20},40,[76],"PHASE2","A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment",[79,80],"Chronic Myeloid Leukemia","Accelerated Phase CML","2025-02-19",{"date":83,"type":32},"2025-02-21",{"date":85,"type":32},"2024-07-15",{"date":87,"type":20},"2028-04-30",{"name":38,"class":39},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100522920","phase-1-tgrx-678-us-phase-i-for-subjects-with-refractory-or-advanced-chronic-myelogenous-leukemia-100522920","NCT06088888","TGRX-678 US Phase I for Subjects with Refractory or Advanced Chronic Myelogenous Leukemia","A Single-arm, Open-label, Dose Escalation + Cohort Expansion Phase 1 Trial on Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-678 in Subjects with Refractory or Advanced Chronic Myelogenous Leukemia","Inclusion Criteria:\n\n* Willing to participate in the study with informed consent;\n* At least 18 years of age at the time of screening;\n* Any sex;\n* Diagnosis of CML-CPduring the screening period;\n* Intolerant or resistant to TKI treatments;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Adequate Absolute neutrophil count (ANC), hemoglobin and platelets levels;\n* Adequate renal and liver function;\n* Normal corrected QT (QTcF) interval as indicated by electrocardiogram (ECG) screening results;\n* Negative blood pregnancy test results for female patients of childbearing potential.\n* Willing to take highly effective contraceptive measures throughout the trial and for 6 months after last dose of investigational drug for female subjects of child-bearing potential or male subject with female partner of child-bearing potential.\n\nExclusion Criteria:\n\n* Exposure to other antineoplastic therapies prior to study enrollment;\n* Exposure to other investigational agent(s) within 14 days of initiating TGRX-678 therapy;\n* Ongoing toxicity from prior therapy greater than grade 1 by CTCAE v. 3 (except alopecia);\n* Hematopoietic cell transplantation \\\u003C 60 days prior to the first dose;\n* Evidence of graft versus host disease (GVHD), whether or not requiring immunosuppressive therapy;\n* Concomitant immunosuppressive therapy (other than short-term corticosteroid treatment);\n* Exposure to drugs related to torsade de pointes;\n* Cytological or pathological diagnosis of active central nervous system disorder;\n* Significant or uncontrolled cardiovascular diseases as defined in the full clinical protocol;\n* Having long QT syndrome, or with family history of idiopathic sudden death or congenital long QT syndrome;\n* Uncontrolled hypertension;\n* Receipt of Traditional Chinese medication or herbal preparations indicated for anti-cancer purposes within 2 weeks prior to the first dose;\n* Severe hemorrhagic disorders unrelated to CML;\n* History of pancreatitis;\n* History of excessive alcohol use;\n* History of elevation in amylase or lipase within 1 year;\n* Have Grade 2 or worse interstitial lung disease or interstitial pneumonitis within 4 weeks prior to Screening;\n* Uncontrolled hypertriglyceridemia;\n* Malabsorption syndrome or other illness that could affect oral absorption.\n* Diagnosis of another primary malignancy in the past 3 years;\n* Reception of major surgery within 14 days prior to the first dose;\n* Active infections that require systemic treatment or other severe infections within 14 days prior to enrollment;\n* Known human immunodeficiency virus (HIV) positive; acute or chronic liver disease (including chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections);\n* Have received or will receive a COVID-19 vaccine within 14 days of study enrollment;\n* Have a positive reverse transcriptase polymerase chain reaction (RT-PCR) test result for SARS-CoV-2 within 2 weeks prior to Screening;\n* Pregnant or breastfeeding female;\n* Female patient of child-bearing potential or male patient who have female partners of child-bearing potential that is unable or unwilling to take highly effective contraceptive measures during the trial and for 6 months after last dose of investigational drug;\n* Significant organ dysfunction that could compromise the patient's safety or the evaluation of the drug's safety in the opinion of the investigator or the medical monitor;\n* Any condition makes participation in this trial inappropriate in the opinion of the investigator or medical monitor;",{"count":48,"type":20},[50],"The purpose of this single-arm, open-label, dose escalation + cohort expansion study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-678 in Chronic Myelogenous Leukemia patients who had failure with or are intolerant to TKI treatments.",[26],{"date":83,"type":32},{"date":102,"type":32},"2024-07-02",{"date":104,"type":20},"2027-06-30",{"name":38,"class":39},2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":65},"100531928","phase-1-tgrx-814-chinese-phase-iii-in-patients-with-hematological-malignancies-100531928","NCT06206174","TGRX-814 Chinese Phase I\u002FII in Patients With Hematological Malignancies","A Single-arm, Open-label, Dose Escalation and Expansion Phase I\u002FII Study Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TGRX-814 Monotherapy and Combination Therapy in Patients With Hematological Malignancies","Inclusion Criteria:\n\n1. male or female ≥ 18 years of age\n2. fully understand the requirements of the study and voluntarily sign a written informed consent form\n3. diagnosis of NHL, ALL, AML or MDS\n4. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2\n5. adequate bone marrow function\n6. patients at high risk for Tumor Lysis Syndrome (TLS) determined by investigator and sponsor for agreement to enroll\n7. adequate disease indicator\n8. adequate coagulation, hepatic and renal function\n9. female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to use a medically approved highly effective contraceptive from the time of signing the Informed Consent Form until at least 3 months after the last dose of study drug; women of childbearing potential must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug\n10. Expected survival time ≥ 12 weeks\n\nExclusion Criteria:\n\n1. received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance\n2. subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma\u002Fleukemia, or post-transplant lymphoproliferative disease (PTLD)\n3. AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia\n4. tumor infiltration of the central nervous system\n5. received allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months\n6. received vaccination within 4 weeks prior to first dose or scheduled to be vaccinated during the study\n7. HBsAg-positive or HBcAb-positive; HCV antibody-positive; HIV antibody-positive\n8. monoclonal antibody antitumor therapy within 4 weeks prior to the first dose; participation in a clinical trial of another interventional drug within 4 weeks prior to the first dose; participation in CAR-T therapy within 12 weeks prior to the first dose; 9. 14 weeks prior to the first dose\n9. received anticancer therapy\u002Finvestigational therapy within 14 days prior to the first dose, or has not recovered from clinically significant toxicity below grade 2 on prior therapy\n10. received steroidal anticancer therapy, CYP3A inhibitors, or CYP3A inducers within 7 days prior to the first dose of study drug\n11. consumption of grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or popcorn within 3 days prior to the first dose of the drug\n12. poorly controlled hypertension; left ventricular ejection fraction ≤ 50% as assessed by cardiac ultrasound; prolonged QT interval; Grade III atrioventricular block or other arrhythmia requiring medical intervention; New York Heart Association (NYHA) Class III or IV congestive heart failure; had myocardial infarction or experienced bypass surgery within 6 months prior to dosing; had arterial or venous thrombotic events within 6 months prior to the first dose of study drug; have other cardiovascular diseases that investigator deemed unfit for enrollment\n13. having a history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the Investigator, would adversely affect the subject's participation in this study\n14. having a history of active malignancy other than NHL, AML, or MDS within 3 years prior to participation in this clinical study\n15. having a condition of malabsorption syndrome or multiple factors that interfere with the oral administration and absorption of medication\n16. other uncontrolled conditions of clinical significance\n17. other factors that, in the opinion of the Investigator, may affect the results of the study and interfere with the patient's participation in the study, including previous or existing medical conditions, abnormalities in treatment or laboratory tests, unwillingness of the subject to comply with the procedures, restrictions and requirements of the study, and other conditions that make enrollment in the study unsuitable.",{"count":115,"type":20},30,[50,76],"The purpose of this single- arm, open-label, dose escalation and dose expansion phase I\u002FII study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.",[55,119,120,121,122],"Non Hodgkin Lymphoma","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia, Adult","Myelodysplastic Syndromes","2024-04-09",{"date":125,"type":32},"2024-04-10",{"date":127,"type":32},"2024-03-06",{"date":129,"type":20},"2029-02-28",{"name":38,"class":39},""]