[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522920":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":19,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":19,"enrollmentInfo":80,"targetDuration":19,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":19,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TGRX-678","EXPERIMENTAL","Subjects to be treated with the investigational drug TGRX-678",[13],"Drug: TGRX-678",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants are given TGRX-678 tablets orally, once daily, at one of the dose levels as pre-determined for the dose escalation sequence or expansion cohorts.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Elias Jabbour","M.D. Anderson Cancer Center","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Xinyi Zhu","CONTACT","86-13061651609","xinyi.zhu@tjrbiosciences.com",[32,51],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The University of Texas MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-95.36327,29.76328,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":19,"email":50},"Elias Jabbour, MD","713-792-4764","ejabbour@mdanderson.org",{"facility":52,"status":34,"city":53,"state":54,"zip":55,"country":38,"countryCode":39,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Fred Hutchinson Cancer Center","Seattle","Washington","98102",{"type":41,"coordinates":57},[58,59],-122.33207,47.60621,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":64,"phoneExt":19,"email":65},"Vivian Oehler, MD","206-667-1340","voehler@fredhutch.org",{"type":67,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[69],{"name":23,"class":70},"OTHER","100522920","phase-1-tgrx-678-us-phase-i-for-subjects-with-refractory-or-advanced-chronic-myelogenous-leukemia-100522920",false,"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;","ALL","18 Years",{"count":81,"type":82},90,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","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.",[88],"Chronic Myelogenous Leukemia","2025-02-19",{"date":91,"type":92},"2025-02-21","ACTUAL",{"date":94,"type":92},"2024-07-02",{"date":96,"type":82},"2027-06-30",{"name":5,"class":6},2]