FX-111: FX-111 will be administered orally once daily in continuous 28-day cycles.
Study summary
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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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.
Trial sites (10)
Facility
City
Region
Status
START Los Angeles
Los Angeles
California
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Not Yet Recruiting
START Midwest
Grand Rapids
Michigan
Recruiting
START New Jersey
East Brunswick
New Jersey
Recruiting
START Carolinas
Myrtle Beach
South Carolina
Recruiting
Tennessee Oncology
Nashville
Tennessee
Not Yet Recruiting
START Dallas-Fort Worth
Fort Worth
Texas
Recruiting
NEXT Houston
Houston
Texas
Recruiting
NEXT Oncology
San Antonio
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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