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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed adenocarcinoma of the prostate. - PSA levels ≥ 2 ng/mL 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.

Exclusion Criteria

  • Predominance of small cell carcinoma of the prostate/neuroendocrine 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FX-111 Dose Level 1
  • Drug: FX-111
    FX-111 will be administered orally once daily in continuous 28-day cycles.
Experimental
FX-111 Dose Level 2
  • Drug: FX-111
    FX-111 will be administered orally once daily in continuous 28-day cycles.
Experimental
FX-111 Dose Level 3
  • Drug: FX-111
    FX-111 will be administered orally once daily in continuous 28-day cycles.
Experimental
FX-111 Dose Level 4
  • Drug: FX-111
    FX-111 will be administered orally once daily in continuous 28-day cycles.
Experimental
FX-111 Dose Level 5
  • Drug: FX-111
    FX-111 will be administered orally once daily in continuous 28-day cycles.

Recruiting Locations

START Los Angeles
Los Angeles, California 90025
Contact:
Hope Team Distribution List
424-465-1820
hopeteam@startresearch.com

START Midwest
Grand Rapids, Michigan 49546
Contact:
Hope Team Distribution List
616-389-1810
hopeteam@startresearch.com

START New Jersey
East Brunswick, New Jersey 08816
Contact:
Nurse Navigator
732-426-4750
dana.sapia@startresearch.com

START Carolinas
Myrtle Beach, South Carolina 29572
Contact:
Kate Valipour, Clinical Research Coordinator
843-449-1010
kate.valipour@startresearch.com

START Dallas-Fort Worth
Fort Worth, Texas 76104
Contact:
Hope Team Distribution List
682-350-3010
hopeteam@startresearch.com

More Details

Status
Recruiting
Sponsor
Flare Therapeutics Inc.

Study Contact

Janine Koucheki, Associate Director, Clinical Operations
857-706-4400
clinops@flaretx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.