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MD",{"type":206,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648366","phase-1-a-study-in-patients-with-metastatic-castration-resistant-prostate-cancer-100648366",false,"NCT07719361","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","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.","MALE","18 Years",{"count":217,"type":218},60,"ESTIMATED","INTERVENTIONAL",[221],"PHASE1","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.",[224,225,226,227,228,229,230,231,232],"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","2026-07-31",{"date":235,"type":236},"2026-08-04","ACTUAL",{"date":238,"type":236},"2026-07-01",{"date":240,"type":218},"2029-02-15",{"name":5,"class":6},10]