[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07719361":3,"trial-entities:NCT07719361":242,"trial-summary:NCT07719361":246},{"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":28,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":51,"sex":70,"minimum_age":71,"maximum_age":17,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":95,"locations":98,"central_contacts":232,"overall_officials":239,"references":240,"see_also_links":241},"NCT07719361","FX-111-CLINPRO-1","A Study in Patients With Metastatic Castration-Resistant Prostate Cancer","A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer","RECRUITING","2029-02-15","2026-07","2026-08-03","2026-07-01","Flare Therapeutics Inc.","INDUSTRY",true,"The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:\n\nWhat are the side effects of FX-111?\n\nDoes FX-111 work to reduce or prevent progression of mCRPC?\n\nThe study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.",null,[19,20,21,22,23,24,25,26,27],"Metastatic Castration Resistant Prostate Cancer","mCRPC","mCRPC (Metastatic Castration-resistant Prostate Cancer)","Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","mCRPC or Advanced\u002FMetastatic Solid Tumors","mCRPC, Metastatic Castration Resistant Prostate Cancer","Neoplasms Prostate","Neoplasms of Prostate",[],"INTERVENTIONAL","TREATMENT",[32],"PHASE1",{"count":34,"type":35},60,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","FX-111","FX-111 will be administered orally once daily in continuous 28-day cycles.",[42,43,44,45,46],"FX-111 Dose Level 1","FX-111 Dose Level 2","FX-111 Dose Level 3","FX-111 Dose Level 4","FX-111 Dose Level 5",[48],{"measure":49,"timeFrame":50},"The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111","Study day 1 throughout the study, estimated to be 6 months.",[52,56,58,60,63,67],{"measure":53,"description":54,"timeFrame":55},"Area Under the Concentration Time Curve","Total body exposure of FX-111","Study day 1 throughout the study for 6 months.",{"measure":57,"timeFrame":55},"Maximum concentration (Cmax) of FX-111 in the bloodstream.",{"measure":59,"timeFrame":55},"Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.",{"measure":61,"timeFrame":62},"Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).","Baseline and every 4 weeks throughout the study, estimated to be 6 months.",{"measure":64,"description":65,"timeFrame":66},"Objective Response Rate (ORR)","The number of patients who achieve either a Complete Response (CR) or Partial Response (PR) to FX-111.\n\nCR: disappearance of all lesions and pathologic lymph nodes. PR: ≥30% decrease in sum of lesions, no new lesions, no progression of non-target lesions.","Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.",{"measure":68,"description":69,"timeFrame":66},"Duration of Response (DoR)","DoR is the time from initial CR or PR until disease progression.","MALE","18 Years",false,{"inclusion":74,"exclusion":84,"raw_text":94},[75,76,77,78,79,80,81,82,83],"Confirmed adenocarcinoma of the prostate.","PSA levels ≥ 2 ng\u002FmL at screening visit.","Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.","Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).","Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.","Acceptable physical functioning and laboratory measurements, per the study protocol.","Discontinued prior therapies within protocol-specified timeframes.","Commit to use of highly-effective contraception while on study and for 90 days after.","Willing and able to adhere to the study visit schedule and other protocol defined requirements.",[85,86,87,88,89,90,91,92,93],"Predominance of small cell carcinoma of the prostate\u002Fneuroendocrine prostate cancer in most recent tumor biopsy.","Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.","Not recovered from side effects of prior surgery or cancer treatments.","Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.","Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).","Blood clots ≤ 4 weeks prior to start of treatment.","Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.","Any evidence of severe or uncontrolled systemic diseases.","Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.","Inclusion Criteria:\n\n* Confirmed adenocarcinoma of the prostate.\n* PSA levels ≥ 2 ng\u002FmL at screening visit.\n* Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.\n* Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).\n* Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.\n* Acceptable physical functioning and laboratory measurements, per the study protocol.\n* Discontinued prior therapies within protocol-specified timeframes.\n* Commit to use of highly-effective contraception while on study and for 90 days after.\n* Willing and able to adhere to the study visit schedule and other protocol defined requirements.\n\nExclusion Criteria:\n\n* Predominance of small cell carcinoma of the prostate\u002Fneuroendocrine prostate cancer in most recent tumor biopsy.\n* Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.\n* Not recovered from side effects of prior surgery or cancer treatments.\n* Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.\n* Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).\n* Blood clots ≤ 4 weeks prior to start of treatment.\n* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.",[96,97],"ADULT","OLDER_ADULT",[99,117,129,142,157,177,188,201,211,221],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":114},"START Los Angeles","Los Angeles","California","90025","United States",[106,111],{"name":107,"role":108,"phone":109,"email":110},"Hope Team Distribution List","CONTACT","424-465-1820","hopeteam@startresearch.com",{"name":112,"role":113},"Navid Hafez, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},34.05223,-118.24368,{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":104,"contacts":123,"geoPoint":126},"Massachusetts General Hospital","NOT_YET_RECRUITING","Boston","Massachusetts","02114",[124],{"name":125,"role":113},"Xin Gao, MD",{"lat":127,"lon":128},42.35843,-71.05977,{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":104,"contacts":134,"geoPoint":139},"START Midwest","Grand Rapids","Michigan","49546",[135,137],{"name":107,"role":108,"phone":136,"email":110},"616-389-1810",{"name":138,"role":113},"Emerson Lim, MD",{"lat":140,"lon":141},42.96336,-85.66809,{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":104,"contacts":147,"geoPoint":154},"START New Jersey","East Brunswick","New Jersey","08816",[148,152],{"name":149,"role":108,"phone":150,"email":151},"Nurse Navigator","732-426-4750","dana.sapia@startresearch.com",{"name":153,"role":113},"Bruno Fang, MD",{"lat":155,"lon":156},40.42788,-74.41598,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":104,"contacts":162,"geoPoint":174},"START Carolinas","Myrtle Beach","South Carolina","29572",[163,168,172],{"name":164,"role":108,"phone":165,"phoneExt":166,"email":167},"Kate Valipour, Clinical Research Coordinator","843-449-1010","5268","kate.valipour@startresearch.com",{"name":169,"role":108,"phone":165,"phoneExt":170,"email":171},"Paige Wilson","5147","paige.wilson@startresearch.com",{"name":173,"role":113},"Neal Shore, MD",{"lat":175,"lon":176},33.68906,-78.88669,{"facility":178,"status":119,"city":179,"state":180,"zip":181,"country":104,"contacts":182,"geoPoint":185},"Tennessee Oncology","Nashville","Tennessee","37203",[183],{"name":184,"role":113},"Katy Beckermann, MD, Ph.D.",{"lat":186,"lon":187},36.16589,-86.78444,{"facility":189,"status":8,"city":190,"state":191,"zip":192,"country":104,"contacts":193,"geoPoint":198},"START Dallas-Fort Worth","Fort Worth","Texas","76104",[194,196],{"name":107,"role":108,"phone":195,"email":110},"682-350-3010",{"name":197,"role":113},"Salwan Al Mutar, MD, M.Sc.",{"lat":199,"lon":200},32.72541,-97.32085,{"facility":202,"status":8,"city":203,"state":191,"zip":204,"country":104,"contacts":205,"geoPoint":208},"NEXT Houston","Houston","77054",[206],{"name":207,"role":113},"Jennifer Segar, MD",{"lat":209,"lon":210},29.76328,-95.36327,{"facility":212,"status":8,"city":213,"state":191,"zip":214,"country":104,"contacts":215,"geoPoint":218},"NEXT Oncology","San Antonio","78229",[216],{"name":217,"role":113},"Ildefonso Ismael Rodriguez Rivera, MD",{"lat":219,"lon":220},29.42412,-98.49363,{"facility":222,"status":8,"city":223,"state":224,"zip":225,"country":104,"contacts":226,"geoPoint":229},"NEXT Virginia","Fairfax","Virginia","22031",[227],{"name":228,"role":113},"Mohamad Salkeni, MD",{"lat":230,"lon":231},38.84622,-77.30637,[233,237],{"name":234,"role":108,"phone":235,"email":236},"Janine Koucheki, Associate Director, Clinical Operations","857-706-4400","clinops@flaretx.com",{"name":238,"role":108,"phone":235,"email":236},"Carolyn McCrone, Sr Clinical Trial Associate",[],[],[],{"nct_id":4,"conditions":243,"biomarkers":245},[244],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":247,"prompt_version":257},{"design":248,"status":249,"heading":250,"summary":251,"follow_up":252,"word_count":253,"commitments":254,"compensation":255,"drugs_mentioned":256},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 adult male participants.","completed","A Study of FX-111 for Metastatic Castration-Resistant Prostate Cancer","This study is testing a drug called FX-111 for men with metastatic castration-resistant prostate cancer (mCRPC). This is prostate cancer that has spread and no longer responds to standard hormone therapy. The main goals are to see if FX-111 is safe, what side effects it might cause, and how your body processes the drug. Researchers also want to learn if FX-111 can help reduce or prevent the cancer from getting worse. You would take FX-111 by mouth once a day in 28-day cycles. The study doctor will monitor your health and tumor status through regular exams and lab tests. This study is currently recruiting up to 60 men who have confirmed prostate cancer that has progressed despite prior treatments.","The number of adverse events will be measured from Study day 1 throughout the study, estimated to be 6 months.",119,"You would take FX-111 orally once daily in continuous 28-day cycles. You will have regular physical and laboratory examinations to check your health and tumor status.","Not stated in the trial record.",[39],"v2"]