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New treatment option for Metastatic Castration Resistant Prostate Cancer
Official title A Study in Patients With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07719361
What this study is testing
What is FX-111?
FX-111 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic castration resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- East Brunswick, New Jersey, United States
- Myrtle Beach, South Carolina, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; East Brunswick, New Jersey, United States; Myrtle Beach, South Carolina, United States; Nashville, Tennessee, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.