[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473954":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":17,"centralContacts":17,"locations":37,"responsibleParty":56,"collaborators":17,"id":58,"slug":17,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":17,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":17,"enrollmentInfo":66,"targetDuration":17,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":17,"overallStatus":40,"whyStopped":17,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Phase 1: MTD and RP2D of HEC169096","Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096","Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study",{"measure":14,"description":15,"timeFrame":16},"Phase 2: Overall Response Rate","As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)","through study completion, an average of 1 year",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","This is an open-label, multi-center Phase 1\u002F2 study in participants with advanced solid tumors, including RET fusion-positive NSCLC, MTC, and other tumors with RET activation. Phase I of this study includes a dose-escalation phase and a dose-expansion phase , which will focus on exploring MTD and\u002For RP2D of HEC169096 in patients with advanced solid tumours; Phase II will assess the efficacy and safety of HEC169096 at the RP2D dose.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"HEC169096","EXPERIMENTAL","Multiple doses of HEC169096",[31],"Drug: HEC169096",[33],{"type":34,"name":27,"description":35,"armGroupLabels":36,"otherNames":17},"DRUG","Multiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.",[27],[38],{"facility":39,"status":40,"city":41,"state":17,"zip":17,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"GuangDong Province Peoples Hospital","RECRUITING","Guangzhou","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":54,"phoneExt":17,"email":55},"Haiyan Tu","CONTACT","13798012949","tuhaiyan@gdph.org.cn",{"type":57,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":67,"type":68},456,"ESTIMATED","INTERVENTIONAL",[71,72],"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.",[75],"Advanced Solid Tumor","2026-04-27",{"date":78,"type":79},"2026-04-28","ACTUAL",{"date":81,"type":79},"2022-10-21",{"date":83,"type":68},"2027-08-30",{"name":5,"class":6},1]