[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577593":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":45,"centralContacts":52,"locations":58,"responsibleParty":183,"collaborators":45,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":45,"eligibilityCriteria":191,"healthyVolunteers":187,"sex":192,"minAge":193,"maxAge":45,"enrollmentInfo":194,"targetDuration":45,"studyType":197,"phases":198,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":61,"whyStopped":45,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"Halda Therapeutics OpCo, Inc.","INDUSTRY",[8,14,20,24,28,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"HLD-0915 Phase 1 Part 1 - Dose Escalation","EXPERIMENTAL","Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13],"Drug: HLD-0915 Hard Capsule",{"label":15,"type":10,"description":16,"interventionNames":17},"HLD-0915 Phase 1 Part 2 - Formulation Exploration","Hard capsule: Single 50mg dose Tablet: Single 50mg dose, followed by daily dosing through Cycle 2. Soft capsule: 50mg daily in 21-day treatment cycles.\n\nTreatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13,18,19],"Drug: HLD-0915 Tablet","Drug: HLD-0915 Soft Capsule",{"label":21,"type":10,"description":22,"interventionNames":23},"HLD-0915 Phase 2 Part 1 - Dose Optimization","Hard Capsules 25mg or 50 mg Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"Phase 2 Part 2A - SOAR","Hard Capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13],{"label":29,"type":10,"description":26,"interventionNames":30},"Phase 2 Part 2B - HSPC Expansion",[13],{"label":32,"type":10,"description":33,"interventionNames":34},"Phase 2 Part 2C - HSPC Expansion","Hard capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13],{"label":36,"type":10,"description":37,"interventionNames":38},"Phase 2 Part 2D - HSPC Expansion","HLD-0915 Hard Capsules Treatment cycle consists of 21 days. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)",[13],[40,46,49],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","HLD-0915 Hard Capsule","Experimental: Oral HLD-0915",[9,15,21,25,29,32,36],null,{"type":41,"name":47,"description":43,"armGroupLabels":48,"otherNames":45},"HLD-0915 Tablet",[15],{"type":41,"name":50,"description":43,"armGroupLabels":51,"otherNames":45},"HLD-0915 Soft Capsule",[15],[53],{"name":54,"role":55,"phone":56,"phoneExt":45,"email":57},"Study Information","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[59,73,83,93,103,113,122,132,142,152,162,171],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":45},"Sarah Cannon Research Institute at HealthONE","RECRUITING","Denver","Colorado","80218","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-104.9847,39.73915,{"lat":71,"lon":70},{"facility":74,"status":61,"city":75,"state":76,"zip":77,"country":65,"countryCode":66,"cosmosGeoPoint":78,"geoPoint":82,"contacts":45},"Yale - New Haven Hospital - Yale Cancer Center","New Haven","Connecticut","06520",{"type":68,"coordinates":79},[80,81],-72.92816,41.30815,{"lat":81,"lon":80},{"facility":84,"status":61,"city":85,"state":86,"zip":87,"country":65,"countryCode":66,"cosmosGeoPoint":88,"geoPoint":92,"contacts":45},"Florida Cancer Specialists","Sarasota","Florida","34232",{"type":68,"coordinates":89},[90,91],-82.53065,27.33643,{"lat":91,"lon":90},{"facility":94,"status":61,"city":95,"state":96,"zip":97,"country":65,"countryCode":66,"cosmosGeoPoint":98,"geoPoint":102,"contacts":45},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":68,"coordinates":99},[100,101],-71.05977,42.35843,{"lat":101,"lon":100},{"facility":104,"status":61,"city":105,"state":106,"zip":107,"country":65,"countryCode":66,"cosmosGeoPoint":108,"geoPoint":112,"contacts":45},"START Midwest, LLC","Grand Rapids","Michigan","49546",{"type":68,"coordinates":109},[110,111],-85.66809,42.96336,{"lat":111,"lon":110},{"facility":114,"status":61,"city":115,"state":115,"zip":116,"country":65,"countryCode":66,"cosmosGeoPoint":117,"geoPoint":121,"contacts":45},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":68,"coordinates":118},[119,120],-74.00597,40.71427,{"lat":120,"lon":119},{"facility":123,"status":61,"city":124,"state":125,"zip":126,"country":65,"countryCode":66,"cosmosGeoPoint":127,"geoPoint":131,"contacts":45},"Duke University Medical Center","Durham","North Carolina","27710",{"type":68,"coordinates":128},[129,130],-78.89862,35.99403,{"lat":130,"lon":129},{"facility":133,"status":61,"city":134,"state":135,"zip":136,"country":65,"countryCode":66,"cosmosGeoPoint":137,"geoPoint":141,"contacts":45},"Carolina Urologic Research Center, LLC","Myrtle Beach","South Carolina","29572",{"type":68,"coordinates":138},[139,140],-78.88669,33.68906,{"lat":140,"lon":139},{"facility":143,"status":61,"city":144,"state":145,"zip":146,"country":65,"countryCode":66,"cosmosGeoPoint":147,"geoPoint":151,"contacts":45},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":68,"coordinates":148},[149,150],-86.78444,36.16589,{"lat":150,"lon":149},{"facility":153,"status":61,"city":154,"state":155,"zip":156,"country":65,"countryCode":66,"cosmosGeoPoint":157,"geoPoint":161,"contacts":45},"NEXT Austin","Austin","Texas","78758",{"type":68,"coordinates":158},[159,160],-97.74306,30.26715,{"lat":160,"lon":159},{"facility":163,"status":61,"city":164,"state":155,"zip":165,"country":65,"countryCode":66,"cosmosGeoPoint":166,"geoPoint":170,"contacts":45},"The University of Texas M.D. Anderson Cancer Center","Houston","77030",{"type":68,"coordinates":167},[168,169],-95.36327,29.76328,{"lat":169,"lon":168},{"facility":172,"status":61,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":45},"Royal Marsden Hospital","Sutton","Surrey","SM2 5PT","United Kingdom","UK",{"type":68,"coordinates":179},[180,181],-0.2,51.35,{"lat":181,"lon":180},{"type":184,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100577593","phase-1-study-of-hld-0915-in-patients-with-metastatic-prostate-cancer-100577593",false,"NCT06800313","Study of HLD-0915 in Patients With Metastatic Prostate Cancer","Phase 1\u002F2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer","Patients must meet the following criteria to be eligible study participation:\n\nKey Inclusion Criteria:\n\nAll Study Arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nMales ≥ 18 years old Histological, pathological, and\u002For cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication\n\nmCRPC Arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen\n\nSOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng\u002FmL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) serum testosterone \\>150ng\u002Fml mHSPC with distant metastatic disease based on conventional imaging and PSA \\>2.0 ng\u002FmL\n\nKey Exclusion Criteria:\n\nAll arms (Phase 1 Part 1 \\& 2, Phase 2 Part 1, Part 2A, 2B, 2C \\& 2D):\n\nHas experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \\>10 mg\u002Fday Prior or ongoing significant medical condition\n\nmCRPC arms: (Phase 1 Part 1 \\& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods\n\nSOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer\n\nmHSPC arms (Phase 2 Part 2B, 2C \\& 2D) regional pelvic lymph node disease only","MALE","18 Years",{"count":195,"type":196},190,"ESTIMATED","INTERVENTIONAL",[199,200],"PHASE1","PHASE2","Assessment of the safety and efficacy of HLD-0915 in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.",[203],"Metastatic Prostate Cancer",[205,206,207,208,209,210,211,212,213,214,215,216],"Prostate Cancer","RIPTAC","HLD-0915","Genital Neoplasms, Male","Urogenital Neoplasms, Male","Genital Diseases, Male","Urogenital Diseases, Male","Neoplasms, Glandular and Epithelial","Prostatic Neoplasms","Prostate Adenocarcinoma","Hormone Sensitive, Castrate Resistant","Metastatic Castrate Resistant Prostate Cancer","2026-06-24",{"date":219,"type":220},"2026-06-26","ACTUAL",{"date":222,"type":220},"2025-02-20",{"date":224,"type":196},"2030-04",{"name":5,"class":6},12]