[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577664":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":115,"collaborators":11,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":11,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":11,"enrollmentInfo":126,"targetDuration":11,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},{"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",[31,45,55,65,75,85,95,105],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":11},"University of California San Diego, Moores Cancer Center","RECRUITING","La Jolla","California","92093","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-117.2742,32.84727,{"lat":43,"lon":42},{"facility":46,"status":33,"city":47,"state":48,"zip":49,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":54,"contacts":11},"Moffitt Cancer Center, Tampa","Tampa","Florida","33612",{"type":40,"coordinates":51},[52,53],-82.45843,27.94752,{"lat":53,"lon":52},{"facility":56,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":11},"University of Maryland, Greenebaum Comprehensive Cancer Center","Baltimore","Maryland","21201",{"type":40,"coordinates":61},[62,63],-76.61219,39.29038,{"lat":63,"lon":62},{"facility":66,"status":33,"city":67,"state":68,"zip":69,"country":37,"countryCode":38,"cosmosGeoPoint":70,"geoPoint":74,"contacts":11},"Harvard Medical School-Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":40,"coordinates":71},[72,73],-71.05977,42.35843,{"lat":73,"lon":72},{"facility":76,"status":33,"city":77,"state":78,"zip":79,"country":37,"countryCode":38,"cosmosGeoPoint":80,"geoPoint":84,"contacts":11},"M Health Fairview Clinics and Surgery Center","Minneapolis","Minnesota","55455",{"type":40,"coordinates":81},[82,83],-93.26384,44.97997,{"lat":83,"lon":82},{"facility":86,"status":33,"city":87,"state":88,"zip":89,"country":37,"countryCode":38,"cosmosGeoPoint":90,"geoPoint":94,"contacts":11},"Xcancer (Urology Cancer Center)","Omaha","Nebraska","68130",{"type":40,"coordinates":91},[92,93],-95.94043,41.25626,{"lat":93,"lon":92},{"facility":96,"status":33,"city":97,"state":98,"zip":99,"country":37,"countryCode":38,"cosmosGeoPoint":100,"geoPoint":104,"contacts":11},"Carolina Urologic Research Center","Myrtle Beach","South Carolina","29572",{"type":40,"coordinates":101},[102,103],-78.88669,33.68906,{"lat":103,"lon":102},{"facility":106,"status":33,"city":107,"state":108,"zip":109,"country":37,"countryCode":38,"cosmosGeoPoint":110,"geoPoint":114,"contacts":11},"Fred Hutchinson Cancer Research Center","Seattle","Washington","98109",{"type":40,"coordinates":111},[112,113],-122.33207,47.60621,{"lat":113,"lon":112},{"type":116,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"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":127,"type":128},67,"ESTIMATED","INTERVENTIONAL",[131],"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).",[134,135],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[9,137,138,139,140,141,142,143,144,145],"castration-resistant prostate cancer","CRPC","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1","2026-04-08",{"date":148,"type":149},"2026-04-09","ACTUAL",{"date":151,"type":149},"2025-05-12",{"date":153,"type":128},"2028-08-01",{"name":155,"class":6},"Acerand Therapeutics (Hong Kong) Limited",8]