[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07567846":3,"trial-entities:NCT07567846":134,"trial-summary:NCT07567846":138},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":79,"locations":82,"central_contacts":117,"overall_officials":125,"references":129,"see_also_links":130},"NCT07567846","GO46445","A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Participants With Advanced or Metastatic Prostate Cancer","A Phase I\u002FII Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic Prostate Cancer","RECRUITING","2027-12-30","2026-07","2026-07-09","2026-04-29","Genentech, Inc.","INDUSTRY",false,"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.",null,[19,20],"Advanced Prostate Cancer","Metastatic Prostate Cancer",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},260,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","GDC-1261","Participants will receive GDC-1261 as per the schedule described in the protocol.",[36],"Dose Escalation + Expansion",[38,41],{"measure":39,"timeFrame":40},"Percentage of Participants With Adverse Events (AEs)","Up to approximately 24 months",{"measure":42,"timeFrame":43},"Incidence and Nature of DLTs Dose-limiting Toxicities (DLTs)","From Day 1-28 of Cycle 1 (1 Cycle = 28 days)",[45,47,49,51,53,55,57],{"measure":46,"timeFrame":40},"Plasma Concentration of GDC-1261",{"measure":48,"timeFrame":40},"Plasma Concentration of GDC-1261 Either in Fasted or Fed State",{"measure":50,"timeFrame":40},"Prostate-Specific Antigen-30% (PSA30) Response Rate",{"measure":52,"timeFrame":40},"PSA50 Response Rate",{"measure":54,"timeFrame":40},"PSA90 Response Rate",{"measure":56,"timeFrame":40},"Objective Response Rate (ORR)",{"measure":58,"timeFrame":40},"Recommended Dose of GDC-1261","MALE","18 Years",{"inclusion":62,"exclusion":70,"raw_text":78},[63,64,65,66,67,68,69],"Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1","Life expectancy is \\>= 3 months","Histologically or cytologically confirmed prostate adenocarcinoma","Disease progression during or following the direct prior line of therapy","Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy","Metastatic disease","Adequate end organ function",[71,72,73,74,75,76,77],"Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives","Structurally unstable bone lesions suggest an impending fracture","Untreated central nervous system (CNS) metastases or leptomeningeal disease","Uncontrolled pain","History of malignancy within 5 years","Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection","Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C=1\n* Life expectancy is \\>= 3 months\n* Histologically or cytologically confirmed prostate adenocarcinoma\n* Disease progression during or following the direct prior line of therapy\n* Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy\n* Metastatic disease\n* Adequate end organ function\n\nExclusion Criteria:\n\n* Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives\n* Structurally unstable bone lesions suggest an impending fracture\n* Untreated central nervous system (CNS) metastases or leptomeningeal disease\n* Uncontrolled pain\n* History of malignancy within 5 years\n* Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection\n* Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results",[80,81],"ADULT","OLDER_ADULT",[83,92,100,109],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Honor Health Research Institute","Scottsdale","Arizona","85258-4566","United States",{"lat":90,"lon":91},33.50921,-111.89903,{"facility":93,"status":8,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"lat":98,"lon":99},36.16589,-86.78444,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"St Vincent's Hospital Sydney","Darlinghurst","New South Wales","2010","Australia",{"lat":107,"lon":108},-33.87939,151.21925,{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":105,"geoPoint":114},"Austin Hospital","Heidelberg","Victoria","3084",{"lat":115,"lon":116},-37.75,145.06667,[118,123],{"name":119,"role":120,"phone":121,"email":122},"Reference Study ID Number: GO46445 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728","global-roche-genentech-trials@gene.com",{"name":124,"role":120},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[126],{"name":127,"affiliation":13,"role":128},"Clinical Trials","STUDY_DIRECTOR",[],[131],{"label":132,"url":133},"Please use this form to submit your questions for a faster response: https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.","https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"nct_id":4,"conditions":135,"biomarkers":137},[136],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]