[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07332455":3,"trial-entities:NCT07332455":227,"trial-summary:NCT07332455":231},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":50,"sex":63,"minimum_age":64,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":65,"std_ages":76,"locations":79,"central_contacts":216,"overall_officials":221,"references":225,"see_also_links":226},"NCT07332455","300164","First-Time-in-Human Study of GSK5471713 in Adults With mCRPC","A Phase 1\u002F2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)","RECRUITING","2030-03-26","2026-07","2026-07-24","2026-02-10","GlaxoSmithKline","INDUSTRY",false,"This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit\u002Frisk of GSK5471713 given as a monotherapy in mCRPC.",null,[19],"Neoplasms, Prostate",[21,22,23,24],"Metastatic castration-resistant prostate cancer","First-Time-in-Human","GSK5471713","Prostate cancer","INTERVENTIONAL","TREATMENT",[28,29],"PHASE1","PHASE2",{"count":31,"type":32},54,"ESTIMATED",[34],{"type":35,"name":23,"description":36,"armGroupLabels":37},"DRUG","GSK5471713 will be administered at different dose levels based on the dose escalation study design",[38],"Participants receiving GSK5471713",[40,43,46,48],{"measure":41,"timeFrame":42},"Number of participants with dose limiting toxicities (DLTs)","28 days",{"measure":44,"timeFrame":45},"Number of participants with adverse events (AEs), and serious adverse events (SAEs)","Approximately 45 months",{"measure":47,"timeFrame":45},"Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity",{"measure":49,"timeFrame":45},"Number of participants with AEs leading to dose modifications",[51,53,55,57,60],{"measure":52,"timeFrame":45},"Maximum plasma concentration (Cmax) of GSK5471713",{"measure":54,"timeFrame":45},"Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713",{"measure":56,"timeFrame":45},"Time to maximum plasma concentration (Tmax) of GSK5471713",{"measure":58,"description":59,"timeFrame":45},"Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate","PSA50 response is defined as a greater than or equal to (\\>=)50 percent (%) decline in PSA from Baseline, confirmed at least 3 weeks later.",{"measure":61,"description":62,"timeFrame":45},"Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment","ORR is defined as the percentage of participants in the ORR Evaluable set who have the Best overall response (BOR) of confirmed Complete response (CR) or Partial response (PR) per PCWG3 guidelines as assessed by investigator.","MALE","18 Years",{"inclusion":66,"exclusion":71,"raw_text":75},[67,68,69,70],"Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.","Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).","Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.","Progression on ADT and \\>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.",[72,73,74],"Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.","Impaired cardiac function or clinically significant cardiac disease.","Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.","Inclusion Criteria:\n\n* Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n* Progression on ADT and \\>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.\n\nExclusion Criteria:\n\n* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.\n* Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion\u002Fexclusion criteria apply.",[77,78],"ADULT","OLDER_ADULT",[80,101,113,125,137,150,163,175,187,195,208],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":98},"GSK Investigational Site","La Jolla","California","92093","United States",[87,92,95],{"name":88,"role":89,"phone":90,"email":91},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":93,"role":89,"phone":94,"email":91},"EU GSK Clinical Trials Call Centre","+44 (0) 20 8990 4466",{"name":96,"role":97},"Rana McKay","PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},32.84727,-117.2742,{"facility":81,"status":8,"city":102,"state":103,"zip":104,"country":85,"contacts":105,"geoPoint":110},"Grand Rapids","Michigan","49546",[106,107,108],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":109,"role":97},"Emerson Lim",{"lat":111,"lon":112},42.96336,-85.66809,{"facility":81,"status":8,"city":114,"state":115,"zip":116,"country":85,"contacts":117,"geoPoint":122},"Philadelphia","Pennsylvania","19107",[118,119,120],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":121,"role":97},"Kevin Zarrabi",{"lat":123,"lon":124},39.95238,-75.16362,{"facility":81,"status":8,"city":126,"state":127,"zip":128,"country":85,"contacts":129,"geoPoint":134},"West Valley City","Utah","84119",[130,131,132],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":133,"role":97},"Jose Pacheco",{"lat":135,"lon":136},40.69161,-112.00105,{"facility":81,"status":8,"city":138,"state":139,"zip":140,"country":141,"contacts":142,"geoPoint":147},"Melbourne","Victoria","3000","Australia",[143,144,145],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":146,"role":97},"Arun Azad",{"lat":148,"lon":149},-37.814,144.96332,{"facility":81,"status":8,"city":151,"state":152,"zip":153,"country":154,"contacts":155,"geoPoint":160},"Toronto","Ontario","M5G 2M9","Canada",[156,157,158],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":159,"role":97},"Srikala Sridhar",{"lat":161,"lon":162},43.70643,-79.39864,{"facility":81,"status":8,"city":164,"state":165,"zip":166,"country":154,"contacts":167,"geoPoint":172},"Montreal","Quebec","H4A 3J1",[168,169,170],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":171,"role":97},"Ramy Saleh",{"lat":173,"lon":174},45.50884,-73.58781,{"facility":81,"status":8,"city":176,"zip":177,"country":178,"contacts":179,"geoPoint":184},"Tokyo","104-0045","Japan",[180,181,182],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":183,"role":97},"Kazuki Sudo",{"lat":185,"lon":186},35.6895,139.69171,{"facility":81,"status":8,"city":176,"zip":188,"country":178,"contacts":189,"geoPoint":194},"135-8550",[190,191,192],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":193,"role":97},"Yuji Miura",{"lat":185,"lon":186},{"facility":81,"status":8,"city":196,"state":197,"zip":198,"country":199,"contacts":200,"geoPoint":205},"Seoul","Seoul Teugbyeolsi","06351","South Korea",[201,202,203],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":204,"role":97},"Se Hoon Park",{"lat":206,"lon":207},37.566,126.9784,{"facility":81,"status":8,"city":196,"zip":209,"country":199,"contacts":210,"geoPoint":215},"120-752",[211,212,213],{"name":88,"role":89,"phone":90,"email":91},{"name":93,"role":89,"phone":94,"email":91},{"name":214,"role":97},"Sang Joon Shin",{"lat":206,"lon":207},[217,218],{"name":88,"role":89,"phone":90,"email":91},{"name":219,"role":89,"phone":220,"email":91},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",[222],{"name":223,"affiliation":13,"role":224},"GSK Clinical Trials","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":228,"biomarkers":230},[229],"Prostate Carcinoma",[],{"nct_id":4,"found":232,"summary":233,"prompt_version":243},true,{"design":234,"status":235,"heading":236,"summary":237,"follow_up":238,"word_count":239,"commitments":240,"compensation":241,"drugs_mentioned":242},"This is a first-time-in-human study, meaning GSK5471713 is being tested in people for the first time. It plans to enroll 54 adult male participants.","completed","First-Time-in-Human Study of GSK5471713 for Metastatic Castration-Resistant Prostate Cancer","This study is testing a new targeted therapy called GSK5471713 for the first time in adults with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and is no longer responding to standard hormone therapy. The main goals are to see how safe GSK5471713 is, how well your body tolerates it, and if it shows any early signs of helping to treat the cancer. Researchers will be looking for side effects and how your body handles the drug. You may be eligible if you are an adult male with mCRPC that has progressed on androgen deprivation therapy (ADT) and have a good general health status (ECOG PS 0 or 1). The current recruitment status is unclear.","Researchers will track side effects for approximately 45 months.",119,"Not specified in the trial record.","Not stated in the trial record.",[23],"v2"]