[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":114,"collaborators":11,"id":116,"slug":11,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":11,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":11,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},{"fullName":5,"class":6},"Acerand Therapeutics Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ACE-232","EXPERIMENTAL",null,[13],"Drug: ACE-232 tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","ACE-232 tablets","ACE-232 tablets will be administered orally daily as a continuous regimen together with Dexamethasone and Fludrocortisone. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Sherwin Cai, MD","CONTACT","86-18983021726","sherwin.cai@acerand.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Teresa Shi, MS","86-13916513539","teresa.shi@acerand.com",[31,44,54,64,74,84,94,104],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":11},"University of California San Diego, Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States",{"type":39,"coordinates":40},"Point",[41,42],-117.2742,32.84727,{"lat":42,"lon":41},{"facility":45,"status":33,"city":46,"state":47,"zip":48,"country":37,"cosmosGeoPoint":49,"geoPoint":53,"contacts":11},"Moffitt Cancer Center, Tampa","Tampa","Florida","33612",{"type":39,"coordinates":50},[51,52],-82.45843,27.94752,{"lat":52,"lon":51},{"facility":55,"status":33,"city":56,"state":57,"zip":58,"country":37,"cosmosGeoPoint":59,"geoPoint":63,"contacts":11},"University of Maryland, Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":39,"coordinates":60},[61,62],-76.61219,39.29038,{"lat":62,"lon":61},{"facility":65,"status":33,"city":66,"state":67,"zip":68,"country":37,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Harvard Medical School-Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":39,"coordinates":70},[71,72],-71.05977,42.35843,{"lat":72,"lon":71},{"facility":75,"status":33,"city":76,"state":77,"zip":78,"country":37,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"M Health Fairview Clinics and Surgery Center","Minneapolis","Minnesota","55455",{"type":39,"coordinates":80},[81,82],-93.26384,44.97997,{"lat":82,"lon":81},{"facility":85,"status":33,"city":86,"state":87,"zip":88,"country":37,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"Xcancer (Urology Cancer Center)","Omaha","Nebraska","68130",{"type":39,"coordinates":90},[91,92],-95.94043,41.25626,{"lat":92,"lon":91},{"facility":95,"status":33,"city":96,"state":97,"zip":98,"country":37,"cosmosGeoPoint":99,"geoPoint":103,"contacts":11},"Carolina Urologic Research Center","Myrtle Beach","South Carolina","29572",{"type":39,"coordinates":100},[101,102],-78.88669,33.68906,{"lat":102,"lon":101},{"facility":105,"status":33,"city":106,"state":107,"zip":108,"country":37,"cosmosGeoPoint":109,"geoPoint":113,"contacts":11},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"type":39,"coordinates":110},[111,112],-122.33207,47.60621,{"lat":112,"lon":111},{"type":115,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100577664",false,"NCT06801236","Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ACE-232 in Patients With Metastatic Castration-Resistant Prostate Cancer (CRPC)","Inclusion Criteria:\n\n* Provide written informed consent\n* Metastatic Castration-resistant Prostate Cancer with ongoing androgen - deprivation therapy (ADT) or have bilateral orchiectomy\n* Difficult to treat or intolerant to standard treatment (post at least 1 line of NHA and taxane-based chemo in mHSPC or mCRPC), suitable for investigational treatment;\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has a life expectancy of at least 6 months\n* Adequate organ function and bone marrow function\n\nExclusion Criteria:\n\n* Receiving any anti-cancer drugs or other treatment, major surgery, extensive radiation therapy, or local radiation therapy within protocol-defined wash-out period;\n* Concomitant use of medications or herbal supplements known to be moderate to strong CYP3A4 inhibitors\u002Finducers, or P-gp inhibitors, known to prolong the QT interval.\n* Any previous treatment-related toxicities have not recovered.\n* Spinal cord compression or known brain metastases or leptomeningeal carcinomatosis.\n* Severe cardiovascular disorders.\n* Known gastrointestinal (GI) disorder or GI procedure\n* History of gastric and duodenal perforation.\n* History of pituitary dysfunction.\n* Poorly controlled diabetes mellitus.\n* Active or uncontrolled autoimmune disease\n* Active infections, or a known history of HIV infection, or a known active hepatitis B or C, or a known active tuberculosis.\n* Other malignancies requiring treatment within 3 years prior to the first dose of study drug\n* Known allergy or hypersensitivity to any of the excipients of ACE-232.\n* Has other medical conditions that at the discretion of the investigator interfere with safety or efficacy evaluation, or treatment compliance.","MALE","18 Years",{"count":125,"type":126},67,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This is an open label, phase I, multi-center study aiming to assess the safety and tolerability in patients with metastatic castration resistant prostate cancer (mCRPC).",[132,133],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[9,135,136,137,138,139,140,141,142,143],"castration-resistant prostate cancer","CRPC","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1","2026-04-08",{"date":146,"type":147},"2026-04-09","ACTUAL",{"date":149,"type":147},"2025-05-12",{"date":151,"type":126},"2028-08-01",{"name":153,"class":6},"Acerand Therapeutics (Hong Kong) Limited",8]