A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

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

  • Metastatic Castration Resistant Prostate Cancer
  • mCRPC
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)
  • Prostatic Neoplasms
  • Prostatic Neoplasms, Castration-Resistant
  • mCRPC or Advanced/Metastatic Solid Tumors
  • mCRPC, Metastatic Castration Resistant Prostate Cancer
  • Neoplasms Prostate
  • Neoplasms of Prostate

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