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: What are the side effects of FX-111? Does FX-111 work to reduce or prevent progression of mCRPC? The 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
FX-111 will be administered orally once daily in continuous 28-day cycles.
START Los Angeles
Los Angeles, California, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART New Jersey
East Brunswick, New Jersey, United States
RECRUITINGSTART Carolinas
Myrtle Beach, South Carolina, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
NOT_YET_RECRUITINGSTART Dallas-Fort Worth
Fort Worth, Texas, United States
RECRUITINGNEXT Houston
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Virginia
Fairfax, Virginia, United States
RECRUITINGThe number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
Time frame: Study day 1 throughout the study, estimated to be 6 months.
Area Under the Concentration Time Curve
Total body exposure of FX-111
Time frame: Study day 1 throughout the study for 6 months.
Maximum concentration (Cmax) of FX-111 in the bloodstream.
Time frame: Study day 1 throughout the study for 6 months.
Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.
Time frame: Study day 1 throughout the study for 6 months.
Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).
Time frame: Baseline and every 4 weeks throughout the study, estimated to be 6 months.
Objective Response Rate (ORR)
The number of patients who achieve either a Complete Response (CR) or Partial Response (PR) to FX-111. CR: disappearance of all lesions and pathologic lymph nodes. PR: ≥30% decrease in sum of lesions, no new lesions, no progression of non-target lesions.
Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
Duration of Response (DoR)
DoR is the time from initial CR or PR until disease progression.
Time frame: Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
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