[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473954":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":39,"collaborators":19,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":19,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":19,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HEC169096","EXPERIMENTAL","Multiple doses of HEC169096",[13],"Drug: HEC169096",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"GuangDong Province Peoples Hospital","RECRUITING","Guangzhou","China","CN",{"type":28,"coordinates":29},"Point",[30,31],113.25,23.11667,{"lat":31,"lon":30},[34],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Haiyan Tu","CONTACT","13798012949","tuhaiyan@gdph.org.cn",{"type":40,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100473954","phase-1-hec169096-in-participants-with-advanced-solid-tumors-100473954",false,"NCT05451602","HEC169096 in Participants With Advanced Solid Tumors","Phase 1\u002F2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1：Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.\n* Phase 2： All participants must have an oncogenic RET-rearrangement\u002Ffusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor.\n* Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n* Measurable or non-measurable disease as determined by RECIST 1.1;\n* Adequate hematologic, hepatic and renal function;\n* Life expectancy of at least 12 weeks;\n* Negative pregnancy test (urine or serum) for female patients of childbearing potential;\n* Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy).\n\nExclusion Criteria:\n\n* Participant's cancer has a known primary driver alteration other than RET.\n* Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment;\n* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment;\n* Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment);\n* Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment;\n* Had received live vaccine within 4 weeks prior to study treatment;\n* Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials;\n* Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment .\n* Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms.\n* Patients with other malignant tumors within 5 years before the first use of drugs\n* Patients have a history of severe cardiovascular disease;\n* Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU\u002F mL or ≥ 10\\^4 cps\u002F mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive.\n* Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment;\n* Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage);\n* Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption;\n* Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.","ALL","18 Years",{"count":51,"type":52},456,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","An Open, Multi-Center Phase I\u002FII Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors.",[59],"Advanced Solid Tumor","2026-04-27",{"date":62,"type":63},"2026-04-28","ACTUAL",{"date":65,"type":63},"2022-10-21",{"date":67,"type":52},"2027-08-30",{"name":5,"class":6},1]