[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553340":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":20,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":20,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: TGRX-1942","EXPERIMENTAL","Patients will be given one of the doses of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, or 60mg orally once a day",[13],"Drug: TGRX-1942",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TGRX-1942","At dose escalation phase, TGRX-1942 will be given orally to patient once a day under a 7-dose sequence of 4mg, 10mg, 20mg, 30mg, 40mg, 50mg, and 60mg. The dose level a particular patient will be assigned depends on the progression of the study and PI evaluation on the safety of previous dose group(s).",[9],null,[22],{"name":23,"affiliation":24,"role":25},"panhongming@zju.edu.cn Pan, MD","Zhejiang University School of Medicine Sir Run Run Shaw Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Hongming Pan, MD","CONTACT","86-0571-86006926","panhongming@zju.edu.cn",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","310009","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[52],{"name":53,"class":54},"Sir Run Run Shaw Hospital","OTHER","100553340","phase-1-tgrx-1942-chinese-phase-i-for-advanced-solid-tumor-andor-relapsedrefractory-hematologic-malignancies-100553340",false,"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","ALL","18 Years",{"count":65,"type":66},90,"ESTIMATED","INTERVENTIONAL",[69],"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",[72,73,74],"Non Small Cell Lung Cancer","Advanced Solid Tumor","Hematologic Malignancy","2025-02-20",{"date":77,"type":78},"2025-02-24","ACTUAL",{"date":80,"type":78},"2024-07-08",{"date":82,"type":66},"2027-06",{"name":5,"class":6},1]