[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Acerand Therapeutics (Hong Kong) Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":19,"type":20},67,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27],"Prostate Cancer (Adenocarcinoma)","mCRPC (Metastatic Castration-resistant Prostate Cancer)",[29,30,31,32,33,34,35,36,37,38],"ACE-232","castration-resistant prostate cancer","CRPC","Hormone Antagonists","Hormone Substitutes","Antineoplastic Agents","Prostatic Neoplasms","Castration-Resistant","prostate cancer","CYP11A1","RECRUITING","2026-04-08",{"date":42,"type":43},"2026-04-09","ACTUAL",{"date":45,"type":43},"2025-05-12",{"date":47,"type":20},"2028-08-01",{"name":49,"class":50},"Acerand Therapeutics (Hong Kong) Limited","INDUSTRY",8,""]