[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":132,"collaborators":20,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":20,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":20,"enrollmentInfo":143,"targetDuration":20,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},{"fullName":5,"class":6},"Acerand Therapeutics Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ACE-232","EXPERIMENTAL","Administered once daily (QD) continuously at the assigned dose level in accordance with the standard 3+3 dose-escalation scheme",[13],"Drug: ACE-232 tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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],null,[22],{"name":23,"affiliation":24,"role":25},"Derek Yang, MD","Acerand Therapeutics","STUDY_DIRECTOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","86-13817816369","derek.yang@acerand.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Teresa Shi, MS","86-13916513539","teresa.shi@acerand.com",[36,50,60,70,80,90,101,111,121],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":20},"University of California San Diego, Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.2742,32.84727,{"lat":48,"lon":47},{"facility":51,"status":38,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":20},"Moffitt Cancer Center, Tampa","Tampa","Florida","33612",{"type":45,"coordinates":56},[57,58],-82.45843,27.94752,{"lat":58,"lon":57},{"facility":61,"status":38,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":20},"University of Maryland, Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":45,"coordinates":66},[67,68],-76.61219,39.29038,{"lat":68,"lon":67},{"facility":71,"status":38,"city":72,"state":73,"zip":74,"country":42,"countryCode":43,"cosmosGeoPoint":75,"geoPoint":79,"contacts":20},"Harvard Medical School-Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":45,"coordinates":76},[77,78],-71.05977,42.35843,{"lat":78,"lon":77},{"facility":81,"status":38,"city":82,"state":83,"zip":84,"country":42,"countryCode":43,"cosmosGeoPoint":85,"geoPoint":89,"contacts":20},"M Health Fairview Clinics and Surgery Center","Minneapolis","Minnesota","55455",{"type":45,"coordinates":86},[87,88],-93.26384,44.97997,{"lat":88,"lon":87},{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":20},"Xcancer (Urology Cancer Center)","WITHDRAWN","Omaha","Nebraska","68130",{"type":45,"coordinates":97},[98,99],-95.94043,41.25626,{"lat":99,"lon":98},{"facility":102,"status":38,"city":103,"state":104,"zip":105,"country":42,"countryCode":43,"cosmosGeoPoint":106,"geoPoint":110,"contacts":20},"Carolina Urologic Research Center","Myrtle Beach","South Carolina","29572",{"type":45,"coordinates":107},[108,109],-78.88669,33.68906,{"lat":109,"lon":108},{"facility":112,"status":38,"city":113,"state":114,"zip":115,"country":42,"countryCode":43,"cosmosGeoPoint":116,"geoPoint":120,"contacts":20},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"type":45,"coordinates":117},[118,119],-122.33207,47.60621,{"lat":119,"lon":118},{"facility":122,"status":38,"city":123,"state":124,"zip":20,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":20},"Fujian Cancer Hospital","Fuzhou","Fujian","China","CN",{"type":45,"coordinates":128},[129,130],119.30611,26.06139,{"lat":130,"lon":129},{"type":133,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100577664","phase-1-phase-1-study-of-ace-232-to-treat-patients-with-metastatic-castration-resistant-prostate-cancer-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":144,"type":145},88,"ESTIMATED","INTERVENTIONAL",[148],"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).",[151,152],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[9,154,155,156,157,158,159,160,161,162],"castration-resistant prostate cancer","CRPC","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1","2026-08-03",{"date":165,"type":166},"2026-08-04","ACTUAL",{"date":168,"type":166},"2025-05-12",{"date":170,"type":145},"2028-12-31",{"name":172,"class":6},"Acerand Therapeutics (Hong Kong) Limited",9]