[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646984":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":29,"enrollmentInfo":63,"targetDuration":29,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":78,"whyStopped":29,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Hyundai Bioscience Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Enzalutamide + CP-PCA07","EXPERIMENTAL","Patients will receive combination therapy with CP-PCA07 and Enzalutamide. Enzalutamide will be administered orally once daily at a fixed dose of 160 mg. CP-PCA07 will be administered orally three times daily, starting at 600 mg\u002Fday, with planned dose escalation to 900 mg\u002Fday and 1,200 mg\u002Fday according to the protocol-specified 3+3 dose-escalation criteria and dose-limiting toxicity evaluation.",[13,14],"Drug: CP-PCA07","Drug: Enzalutamide 40 mg capsule",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","CP-PCA07","CP-PCA07 will be administered orally three times daily. The starting dose is 600 mg\u002Fday, with planned escalation to 900 mg\u002Fday and 1,200 mg\u002Fday based on protocol-specified 3+3 dose-escalation criteria and dose-limiting toxicity evaluation.",[9],[22],"Niclosamide",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Enzalutamide 40 mg capsule","Enzalutamide will be administered orally once daily at a fixed dose of 160 mg, with or without food, in combination with CP-PCA07.",[9],[28],"Xtandi",null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Hyundai Bioscience Clinical Trial Inquiries","CONTACT","+82-1544-3194","clinical@hyundaibio.com",[37],{"facility":38,"status":29,"city":39,"state":29,"zip":40,"country":41,"countryCode":29,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":43,"coordinates":44},"Point",[45,46],126.9784,37.566,{"lat":46,"lon":45},[49],{"name":50,"role":51,"phone":29,"phoneExt":29,"email":29},"Chang Wook Jeong, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100646984","phase-1-safety-tolerability-and-efficacy-of-cp-pca07-in-combination-with-enzalutamide-in-patients-with-castration-resistant-prostate-cancer-100646984",false,"NCT07683013","Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer","An Open-Label, Dose-Escalation, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* 1\\. Male patients aged ≥19 years at the time of providing written informed consent.\n* 2\\. Patients with histologically or cytologically confirmed castration-resistant prostate cancer without small-cell features, who have experienced treatment failure with monotherapy of Enzalutamide or Abiraterone.\n* 3\\. Patients with a serum testosterone level \\\u003C 50 ng\u002FdL at screening.\n* 4\\. Patients with an increase in PSA compared to baseline, confirmed by two consecutive measurements within 8 weeks prior to the date of written informed consent (with at least 1 week between measurements and an increase of ≥ 50% compared to baseline).\n* 5\\. Patients with PSA levels ≥ 2 ng\u002FmL both prior to the date of written informed consent and at screening.\n* 6\\. Patients with an ECOG performance status ≤ 2 and an expected survival of at least 6 months.\n* 7\\. Patients whose spouse or partner is a woman of childbearing potential must agree to use one of the protocol-specified highly effective methods of contraception from the time of study participation consent until 3 months after the last administration of the investigational product.\n* 8\\. Patients who voluntarily agree to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients who have received chemotherapy, chemoradiotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to the first administration of the investigational product (for docetaxel or cabazitaxel therapy, within 9 weeks prior to the screening date).\n* 2\\. Patients diagnosed with immunodeficiency or who are in an immune-suppressed condition.\n* 3\\. Patients with autoimmune diseases.\n* 4\\. Patients with a pacemaker or severe heart failure \\[Class III or IV heart failure according to the New York Heart Association (NYHA) classification\\], or patients with uncontrolled arrhythmia (all patients with implanted medical devices other than a pacemaker are excluded).\n* 5\\. Patients with a history of chronic liver disease or evidence of cirrhosis.\n* 6\\. Patients with a history of gastrectomy or other conditions that may affect drug absorption.\n* 7\\. Patients with a history of deep vein thrombosis, pulmonary embolism, acute coronary syndrome, or major cerebrovascular disease within 6 months prior to screening.\n* 8\\. Patients with a history of major surgery requiring general anesthesia or assisted ventilation within 4 weeks prior to screening.\n* 9\\. Patients with active hepatitis B, a history of hepatitis B, or known active hepatitis C virus infection at screening.\n* 10\\. Patients who meet any of the following laboratory criteria at screening:\n* ① Absolute neutrophil count (ANC) \\\u003C 1,500\u002FuL without G-CSF administration within 2 weeks prior to screening\n* ② Platelet \\\u003C 100,000\u002FuL without transfusion within 2 weeks prior to screening\n* ③ Hemoglobin \\\u003C 9.0 g\u002FdL without transfusion within 2 weeks prior to screening\n* ④ Serum creatinine \\> 1.8 mg\u002FdL or eGFR (or GFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2\n* ⑤ AST and ALT \\> 2.5 x ULN\n* ⑥ Total bilirubin \\> 2.0 x ULN\n* 11\\. Patients expected to have hypersensitivity to the active ingredient or components of the investigational product.\n* 12\\. Patients who have received another investigational drug or investigational medical device within 4 weeks prior to the first administration of the investigational product.\n* 13\\. Patients deemed by the investigator to be unsuitable for participation in the study or unable to comply with the study requirements due to other diseases or conditions.","MALE","19 Years",{"count":64,"type":65},18,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The purpose of this clinical study is to evaluate the safety, tolerability, and efficacy of CP-PCA07 in combination with enzalutamide in patients with castration-resistant prostate cancer (CRPC).\n\nThis is an open-label, dose-escalation, multicenter Phase 1 study. The primary objective is to assess the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) to determine the recommended Phase 2 dose (RP2D) of the combination therapy.\n\nThe secondary objective is to assess changes in Prostate-Specific Antigen (PSA) levels and pharmacokinetic characteristics.\n\nExploratory objectives include assessment of tumor response, disease control, progression-free survival, and biomarker analyses, including AR-V7 status, according to RECIST version 1.1 and other applicable criteria.",[71],"Castration-Resistant Prostate Cancer (CRPC)",[73,74,18,75,22,76,77],"Castration-resistant prostate cancer","CRPC","Enzalutamide","Phase 1","Dose escalation","NOT_YET_RECRUITING","2026-07-02",{"date":81,"type":82},"2026-07-06","ACTUAL",{"date":84,"type":65},"2026-07",{"date":86,"type":65},"2027-12",{"name":5,"class":6},1]