[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659854":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":27,"interventions":60,"overallOfficials":20,"centralContacts":90,"locations":96,"responsibleParty":272,"collaborators":20,"id":274,"slug":275,"hasResults":276,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":20,"eligibilityCriteria":280,"healthyVolunteers":276,"sex":281,"minAge":282,"maxAge":20,"enrollmentInfo":283,"targetDuration":20,"studyType":286,"phases":287,"briefSummary":289,"conditions":290,"keywords":20,"overallStatus":154,"whyStopped":20,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"TransThera Sciences (Nanjing), Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Stage A: safety evaluation parameters","Including dose-limiting toxicities (DLTs), and incidence, duration, and severity of other adverse events (AEs)","From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.",{"measure":14,"description":15,"timeFrame":16},"Stage B: 6-month PFS rate (6mo-PFS)","The proportion of patients who remain alive without disease progression at 6 months after study treatment initiation. Tumor assessments are based on RECIST v1.1 and\u002For PCWG3.","From first study drug administration to the end of treatment, an average of 1 year.",{"measure":18,"description":19,"timeFrame":16},"Stage C: Radiographic progression-free survival (rPFS）","The time from randomization or treatment initiation to the first documented radiographic disease progression or death from any cause, whichever occurs first. Tumor assessments are based on RECIST v1.1 and\u002For PCWG3.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":20},"NONE",[28,33,37,41,46,51,56],{"label":29,"type":30,"description":20,"interventionNames":31},"Stage A (tinengotinib plus darolutamide)","EXPERIMENTAL",[32],"Drug: tinengotinib 10 mg QD plus darolutamide",{"label":34,"type":30,"description":20,"interventionNames":35},"Stage A (tinengotinib (2-week on \u002F 1-week off) plus darolutamide)",[36],"Drug: tinengotinib 10 mg QD (2-week on \u002F 1-week off) plus darolutamide",{"label":38,"type":30,"description":20,"interventionNames":39},"Stage A (tinengotinib plus enzalutamide)",[40],"Drug: tinengotinib 10 mg QD plus enzalutamide",{"label":42,"type":30,"description":43,"interventionNames":44},"Stage B (combination therapy)","optimized combination regimen",[45],"Drug: preferred combination regimen of tinengotinib plus one ARPI",{"label":47,"type":30,"description":48,"interventionNames":49},"Stage C (combination therapy)","selected combination regimen",[50],"Drug: selected combination regimen of tinengotinib plus one ARPI",{"label":52,"type":53,"description":20,"interventionNames":54},"Stage C (ARPI monotherapy therapy)","ACTIVE_COMPARATOR",[55],"Drug: Darolutamide 600 mg twice daily",{"label":57,"type":53,"description":20,"interventionNames":58},"Stage C (physician choice)",[59],"Drug: Enzalutamide 160mg daily (oral)",[61,66,70,74,78,82,86],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":20},"DRUG","tinengotinib 10 mg QD plus darolutamide","Participants will receive tinengotinib 10 mg once daily with darolutamide in 21-day cycles per protocol defined schedule.",[29],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":20},"tinengotinib 10 mg QD (2-week on \u002F 1-week off) plus darolutamide","Participants will receive tinengotinib 10 mg once daily (2-week on \u002F 1-week off) with darolutamide in 21-day cycles per protocol defined schedule.",[34],{"type":62,"name":71,"description":72,"armGroupLabels":73,"otherNames":20},"tinengotinib 10 mg QD plus enzalutamide","Participants will receive tinengotinib 10 mg once daily with enzalutamide in 21-day cycles per protocol defined schedule.",[38],{"type":62,"name":75,"description":76,"armGroupLabels":77,"otherNames":20},"preferred combination regimen of tinengotinib plus one ARPI","Participants will receive preferred combination regimen of tinengotinib at optimized dose plus one ARPI in 21-day cycles per protocol defined schedule.",[42],{"type":62,"name":79,"description":80,"armGroupLabels":81,"otherNames":20},"selected combination regimen of tinengotinib plus one ARPI","Participants will receive selected combination regimen of tinengotinib at optimized dose plus one ARPI in 21-day cycles per protocol defined schedule.",[47],{"type":62,"name":83,"description":84,"armGroupLabels":85,"otherNames":20},"Darolutamide 600 mg twice daily","Participants will receive darolutamide 600 mg twice daily in 21-day cycles per protocol defined schedule.",[52],{"type":62,"name":87,"description":88,"armGroupLabels":89,"otherNames":20},"Enzalutamide 160mg daily (oral)","Participants will receive enzalutamide 160mg daily (oral) in 21-day cycles per protocol defined schedule.",[57],[91],{"name":92,"role":93,"phone":94,"phoneExt":20,"email":95},"Caixia Sun, MD","CONTACT","025-58216298","sun_caixia@transtherabio.com",[97,113,124,132,144,152,165,175,187,199,211,222,233,244,254,265],{"facility":98,"status":99,"city":100,"state":101,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"The First Affiliated Hospital of Fujian Medical University","NOT_YET_RECRUITING","Fuzhou","Fujian","China","CN",{"type":105,"coordinates":106},"Point",[107,108],119.30611,26.06139,{"lat":108,"lon":107},[111],{"name":112,"role":93,"phone":20,"phoneExt":20,"email":20},"Xue",{"facility":114,"status":99,"city":115,"state":116,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Nanfang Hospital, Southern Medical University","Guangzhou","Guangdong",{"type":105,"coordinates":118},[119,120],113.25,23.11667,{"lat":120,"lon":119},[123],{"name":112,"role":93,"phone":20,"phoneExt":20,"email":20},{"facility":125,"status":99,"city":115,"state":116,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":126,"geoPoint":128,"contacts":129},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University",{"type":105,"coordinates":127},[119,120],{"lat":120,"lon":119},[130],{"name":131,"role":93,"phone":20,"phoneExt":20,"email":20},"Lin",{"facility":133,"status":99,"city":134,"state":135,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei",{"type":105,"coordinates":137},[138,139],114.26667,30.58333,{"lat":139,"lon":138},[142],{"name":143,"role":93,"phone":20,"phoneExt":20,"email":20},"Wang",{"facility":145,"status":99,"city":134,"state":135,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"Zhongnan Hospital of Wuhan University",{"type":105,"coordinates":147},[138,139],{"lat":139,"lon":138},[150],{"name":151,"role":93,"phone":20,"phoneExt":20,"email":20},"Yu",{"facility":153,"status":154,"city":155,"state":156,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Affiliated Drum Tower Hospital, Medical School of Nanjing University","RECRUITING","Nanjing","Jiangsu",{"type":105,"coordinates":158},[159,160],118.77778,32.06167,{"lat":160,"lon":159},[163],{"name":164,"role":93,"phone":20,"phoneExt":20,"email":20},"Guo",{"facility":166,"status":99,"city":167,"state":156,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Nantong Cancer Hospital","Nantong",{"type":105,"coordinates":169},[170,171],120.87472,32.03028,{"lat":171,"lon":170},[174],{"name":143,"role":93,"phone":20,"phoneExt":20,"email":20},{"facility":176,"status":99,"city":177,"state":178,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Shandong Cancer Hospital and Institute, Shandong First Medical University","Jinan","Shandong",{"type":105,"coordinates":180},[181,182],116.99722,36.66833,{"lat":182,"lon":181},[185],{"name":186,"role":93,"phone":20,"phoneExt":20,"email":20},"Bian",{"facility":188,"status":99,"city":189,"state":190,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Sichuan Cancer Hospital","Chengdu","Sichuan",{"type":105,"coordinates":192},[193,194],104.06667,30.66667,{"lat":194,"lon":193},[197],{"name":198,"role":93,"phone":20,"phoneExt":20,"email":20},"Liao",{"facility":200,"status":99,"city":201,"state":202,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang",{"type":105,"coordinates":204},[205,206],120.16142,30.29365,{"lat":206,"lon":205},[209],{"name":210,"role":93,"phone":20,"phoneExt":20,"email":20},"Zhang",{"facility":212,"status":99,"city":213,"state":202,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"The First Hospital of Jiaxing","Jiaxing",{"type":105,"coordinates":215},[216,217],120.75,30.7522,{"lat":217,"lon":216},[220],{"name":221,"role":93,"phone":20,"phoneExt":20,"email":20},"He",{"facility":223,"status":99,"city":224,"state":202,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"The First Affiliated Hospital of Ningbo University","Ningbo",{"type":105,"coordinates":226},[227,228],121.54945,29.87819,{"lat":228,"lon":227},[231],{"name":232,"role":93,"phone":20,"phoneExt":20,"email":20},"Ma",{"facility":234,"status":99,"city":235,"state":202,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"The First Affiliated Hospital of Wenzhou Medical University","Wenzhou",{"type":105,"coordinates":237},[238,239],120.66682,27.99942,{"lat":239,"lon":238},[242],{"name":243,"role":93,"phone":20,"phoneExt":20,"email":20},"Chen",{"facility":245,"status":99,"city":246,"state":20,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Peking University Third Hospital","Beijing",{"type":105,"coordinates":248},[249,250],116.39723,39.9075,{"lat":250,"lon":249},[253],{"name":210,"role":93,"phone":20,"phoneExt":20,"email":20},{"facility":255,"status":99,"city":256,"state":20,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Chongqing University Cancer Hospital","Chongqing",{"type":105,"coordinates":258},[259,260],106.55771,29.56026,{"lat":260,"lon":259},[263],{"name":264,"role":93,"phone":20,"phoneExt":20,"email":20},"Li",{"facility":266,"status":99,"city":256,"state":20,"zip":20,"country":102,"countryCode":103,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"The First Affiliated Hospital of Chongqing Medical University",{"type":105,"coordinates":268},[259,260],{"lat":260,"lon":259},[271],{"name":143,"role":93,"phone":20,"phoneExt":20,"email":20},{"type":273,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100659854","phase-2-safety-efficacy-and-pharmacokinetics-of-tt00420-tablets-combined-with-novel-endocrine-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100659854",false,"NCT07871110","Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Progressing After Prior Treatment","Inclusion Criteria:\n\n1. Male aged \\>= 18 years at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed prostate adenocarcinoma; neuroendocrine differentiation after prior treatment is permitted (patients with de novo neuroendocrine prostate cancer at initial diagnosis are excluded).\n3. Baseline imaging confirming metastatic lesions in bone (\\>=2 bone lesions) or soft tissue; lesions identified only by PET imaging are not acceptable.\n4. Receipt of continuous medical castration for \\>=90 days or prior surgical castration, with serum testosterone \\\u003C 50 ng\u002FdL (1.73 nmol\u002FL) within 28 days prior to the first dose. Participants receiving medical castration with a luteinizing hormone-releasing hormone (LHRH) analogue must continue treatment throughout the study.\n5. Documented disease progression (per RECIST v1.1 and\u002For PCWG3) after \\>1 month of prior novel endocrine therapy (including abiraterone and AR inhibitors).\n\n   Cohort B: Prior exposure to only one type of novel endocrine therapy.\n6. Disease failure after \\\u003C=1 line of chemotherapy administered during the castration-resistant phase (chemotherapy duration \\\u003C=1 month and ADC agents are not counted as systemic chemotherapy).\n7. ECOG performance status \\\u003C= 1.\n8. Adequate organ and bone marrow function (no hematopoietic growth factors, blood transfusion or related blood products within 14 days before the first dose).\n9. Must agree not to donate sperm or cryopreserve sperm for future assisted reproduction during study treatment and for 3 months after the last dose of study treatment. If the participant is spermatogenic and his female partner is of childbearing potential, highly effective contraception must be used.\n10. Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Prior treatment with tyrosine kinase inhibitors (TKIs).\n2. Prior treatment with darolutamide or enzalutamide (except for treatment duration \\\u003C= 1 month).\n3. Uncontrolled hypertension (systolic blood pressure \\>=150 mmHg or diastolic blood pressure \\>=100 mmHg; repeat measurement is permitted after an interval of \\>=10 minutes if abnormal), or a medical history of hypertensive crisis\u002Fhypertensive encephalopathy. Uncontrolled is defined as failure to achieve blood pressure control despite antihypertensive therapy with stable type\u002Fdose for at least 1 week.\n4. Concurrent central nervous system (CNS) metastases with radiological or symptomatic progression within 28 days prior to study treatment initiation.\n5. Concurrent other malignancies requiring active treatment. Malignancies not requiring treatment within 5 years and cured localized tumors such as basal cell carcinoma of the skin, papillary thyroid carcinoma, etc., are excluded from this criterion.\n6. Prior administration of other anti-tumor therapies within \\\u003C=5 half-lives or 14 days (whichever is shorter) before initiation of study treatment, or failure to recover from adverse events of prior therapy (except for adverse events \\\u003C= Grade 1 or \\\u003C= Grade 2 adverse events judged by the investigator not to pose a safety risk). Sex hormone therapies other than LHRH agents must be discontinued \\>=7 days before study drug administration.\n7. Receipt of extensive radiotherapy within 4 weeks prior to study treatment initiation, or palliative local radiotherapy within 2 weeks, or failure to recover from adverse events of prior therapy. (If the investigator considers that early initiation of study drug is in the participant's best interest based on benefit-risk assessment, study drug treatment may be started during the washout period upon sponsor approval.)\n8. Major surgery within 4 weeks prior to study treatment initiation, or failure to recover from surgical adverse events (except for adverse events \\\u003C= Grade 1 or \\\u003C= Grade 2 adverse events judged by the investigator not to pose a safety risk). 9. History of severe cardiovascular or cerebrovascular diseases.\n\n10\\. Severe gastrointestinal disease or gastrointestinal dysfunction that may alter the absorption, metabolism or excretion of the study drug; eligibility will be determined by investigator assessment (including but not limited to total gastrectomy, short bowel syndrome, etc.).\n\n11\\. Bleeding disorders, thrombotic disorders, or therapeutic anticoagulation requiring INR monitoring, such as warfarin or any other coumarin derivative anticoagulants.\n\n12\\. Use of strong CYP3A4 inhibitors and other agents that may affect the metabolism of the study drug within \\\u003C=2 weeks or 5 half-lives (whichever is shorter) prior to study treatment initiation. Other agents that may affect the concomitant medications are as follows: (1) Participants receiving enzalutamide combination therapy: use of strong CYP2C8 inhibitors; (2) Participants receiving darolutamide combination therapy: use of rosuvastatin, strong P-gp inhibitors and inducers.\n\n13\\. Positive human immunodeficiency virus (HIV) test. 14. Active HBV infection (abnormal HBV serology other than positive hepatitis B surface antibody; HBV DNA copy number testing is required to confirm activity) and\u002For HCV infection (HCV RNA copy number testing is required to confirm activity if HCV antibody is positive).\n\n15\\. Inability to swallow or tolerate oral medication. 16. Other conditions judged by the investigator to make the participant unsuitable for study participation.","MALE","18 Years",{"count":284,"type":285},182,"ESTIMATED","INTERVENTIONAL",[288],"PHASE2","The goal of this clinical trial is to learn if tinengotinib combined with darolutamide or enzalutamide works to treat participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitors (ARPIs). It will also learn about the safety of the combination therapy. The main questions it aims to answer are:\n\n1. If participants with mCRPC can benefit from the combination therapy of tinengotinib plus one ARPI?\n2. What medical problems do participants have when taking the combination therapy? Participants will take tinengotinib with darolutamide or enzalutamide to find the optimal dose and regimen of tinengotinib for the combination therapy in stage A. In stage B, participants will take preferred combination regimen of tinengotinib plus darolutamide\u002Fenzalutamide identified in stage A. In stage C, researchers will compare selected combination therapy versus standard treatment and\u002For monotherapy to see if the combination therapy works better.",[291],"Prostate Cancer (CRPC)","2026-10-07",{"date":294,"type":295},"2026-10-13","ACTUAL",{"date":297,"type":295},"2026-09-18",{"date":299,"type":285},"2029-06-30",{"name":5,"class":6},16]